OMNISPAN ORTHOCORD 228140Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10886705010028), received between Jun 13, 2018 and Jan 24, 2023 — classified as 5 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 reports).

5 other recalls cover devices cleared under the same FDA submission (K092836, K150209); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN THAILAND THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SECOND STITCH ON THE OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE DEVICE DID NOT DEPLOY INTO THE MENISCUS AND WAS STUCK IN THE NEEDLE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16235339 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (B)(4) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14991297 ↗
• MalfunctionMar 1, 2022Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN (B)(4) THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SECOND IMPLANT DID NOT DEPLOY IN THE MENISCUS; AND WAS STUCK IN THE NEEDLE ON THE OMNISPAN MENISCAL REPAIR, 0DEG DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635671 ↗
• InjuryJul 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY DISTRIBUTOR VIA EMAIL THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION + MENISCUS SUTURE, THREE MENISCAL APPLIER, OMNISPAN, DID NOT FIRE THE NEEDLE, TWO OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE WERE OPENED AND FIRED, BUT THEN STOPPED. THEN THEY OPENED A OMNISPAN MENISCAL REPAIR SYSTEM/12 DEGREE WHICH FIRED THREE NEEDLES BUT THEY DID NOT HOLD. SHOTS WERE MADE WITH THE APPLICATOR BUT THE NEEDLES DID NOT HOLD TO THE MENISCUS. THE SURGERY WAS CONVERTED TO OPEN TO SOLVE PROBLEM. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. DEVICES WERE DISCARDED.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10225200 ↗
• InjuryJul 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY DISTRIBUTOR VIA EMAIL THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION + MENISCUS SUTURE, THREE MENISCAL APPLIER, OMNISPAN, DID NOT FIRE THE NEEDLE, TWO OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE WERE OPENED AND FIRED, BUT THEN STOPPED. THEN THEY OPENED A OMNISPAN MENISCAL REPAIR SYSTEM/12 DEGREE WHICH FIRED THREE NEEDLES BUT THEY DID NOT HOLD. SHOTS WERE MADE WITH THE APPLICATOR BUT THE NEEDLES DID NOT HOLD TO THE MENISCUS. THE SURGERY WAS CONVERTED TO OPEN TO SOLVE PROBLEM. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. DEVICES WERE DISCARDED.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10225117 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING A KNEE SURGERY WHEN THE NEEDLE OF THE OMNISPAN MENISCAL REPAIR, 0DEG WAS INSERTED INTO THE JOINT IT MADE A DOUBLE DEPLOYMENT, AS PER THE SURGEON THE NEEDLES WERE REMOVED AND THEY USED A NEW OMNISPAN MENISCAL REPAIR, 0DEG BUT THE SAME ISSUE OCCURRED, A DOUBLE DEPLOYMENT WAS MADE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) OMNISPAN MENISCAL REPAIR, 0DEG. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239812 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  UPDATED: DURING THE IMPLANT THE CORRECT ORDER OF TRIGGERS WAS PULLED. THE NEEDLE WAS IN THE CORRECT ORIENTATION. THE NEEDLE DID NOT OVER PENETRATE THE MENISCUS. THE SURGEON MAINTAINED THE APPROPRIATE TECHNIQUE AND POSITION. NO IMPLANTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW OMNISPAN IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239802 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE TWO OMNISPAN MENISCAL REPAIR, 0DEG HAD A DOUBLE DEPLOYMENT WHEN THE FIRST NEEDLE WAS INTENDED TO BE INSERTED THE TWO NEEDLES CAME OUT. THE SAME SITUATION HAPPENED FOR THE TWO UNITS. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) OMNISPAN MENISCAL REPAIR, 0DEG THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239627 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE TWO OMNISPAN MENISCAL REPAIR, 0DEG HAD A DOUBLE DEPLOYMENT WHEN THE FIRST NEEDLE WAS INTENDED TO BE INSERTED THE TWO NEEDLES CAME OUT. THE SAME SITUATION HAPPENED FOR THE TWO UNITS. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) OMNISPAN MENISCAL REPAIR, 0DEG. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239625 ↗
• MalfunctionJul 3, 2019Component Missing; Component Missing

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT PRIOR TO A PROCEDURE THE OMNISPAN MENISCAL REPAIR 0 DEGREE WAS BRAND NEW AND THE PHYSICIAN COULD NOT FIND THE SECOND NEEDLE PART. ANOTHER PRODUCT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. NO CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761410 ↗
• InjuryApr 2, 2019Activation, Positioning or Separation Problem; Incomplete or Inadequate Connection; Activation, Positioning or Separation Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE FIRST IMPLANT WAS POSITIONED CORRECTLY IN THE APPLICATOR, BUT WHEN THE DOCTOR USED THE CORRECT TECHNIQUE (USING A MALLEABLE HEMICANUKA) AFTER HAVING CROSSED THE MENISCUS, THE IMPLANT WOULD NOT DISCHARGE FROM THE GUN DESPITE HAVING REPEATEDLY PRESSING THE TRIGGER. THE SECOND IMPLANT WAS POSITIONED CORRECTLY IN THE APPLICATOR, BUT WHEN THE DOCTOR USED THE CORRECT TECHNIQUE (USING A MALLEABLE HEMICANUKA) AFTER HAVING CROSSED THE MENISCUS AND FIRED THE FIRST IMPLANT, WHEN POSITIONING THE SECOND IMPLANT A FEW MILLIMETERS, EVERY SYSTEM CAME OUT OF THE APPLICATOR. THE SURGEON DID NOT WANT TO CONTINUE HURTING THE MENISCUS WITH MENISCAL SUTURE AND SO CHOSE TO DO A MENISCECTOMY INSTEAD.

  Patient problems: No Code Available

  MAUDE report 8473225 ↗
• InjuryApr 2, 2019Disconnection; Device-Device Incompatibility; Disconnection; Device-Device Incompatibility

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE FIRST IMPLANT WAS POSITIONED CORRECTLY IN THE APPLICATOR, BUT WHEN THE DOCTOR USED THE CORRECT TECHNIQUE (USING A MALLEABLE HEMICANUKA) AFTER HAVING CROSSED THE MENISCUS, THE IMPLANT WOULD NOT DISCHARGE FROM THE GUN DESPITE HAVING REPEATEDLY PRESSING THE TRIGGER. THE SECOND IMPLANT WAS POSITIONED CORRECTLY IN THE APPLICATOR, BUT WHEN THE DOCTOR USED THE CORRECT TECHNIQUE (USING A MALLEABLE HEMICANUKA) AFTER HAVING CROSSED THE MENISCUS AND FIRED THE FIRST IMPLANT, WHEN POSITIONING THE SECOND IMPLANT A FEW MILLIMETERS, EVERY SYSTEM CAME OUT OF THE APPLICATOR. THE SURGEON DID NOT WANT TO CONTINUE HURTING THE MENISCUS WITH MENISCAL SUTURE AND SO CHOSE TO DO A MENISCECTOMY INSTEAD.

  Patient problems: No Code Available

  MAUDE report 8473162 ↗
• MalfunctionMar 29, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN ACL PROCEDURE THE MENISCAL SUTURE TECHNIQUE IS STARTED AND IT WAS WANTED TO PASS THE FIRST POINT TO THE MENISCUS AND WHEN THE GUN WAS ACTIVATED, TWO STITCHES WERE SKIPPED AT THE SAME TIME. THE SPECIALISTS STATED THAT THE PRODUCT WAS PRESENTING FAULTS AND DECIDED TO NOT USE IT OR MAKE SUTURE TO THE MENISCUS AND SUGGESTED THAT THE DEVICES BE SENT FOR QUALITY CONTROL. THE AFFILIATE REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ALTERNATION TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464572 ↗
• MalfunctionJan 29, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED BY THE SALES REP THAT THE NEEDLE IN HIS OMNISPAN MENISCAL REPAIR, 0-DEGREE BENT DURING A MENISCAL REPAIR SURGICAL PROCEDURE. THE SALES REP STATED THAT THE NEEDLE BENT WHEN GOING THROUGH THE MENISCUS AT AN AWKWARD ANGLE. THE CASE WAS COMPLETED WITH ANOTHER NEEDLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286615 ↗
• MalfunctionJan 29, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A RECONSTRUCTION SURGERY OF ANTERIOR LIGAMENT, IT REQUIRED MENISCAL SUTURE. AN ONMINSPAN 0° WAS USED AND IT DIDN¿T DOWNLOAD THE POINTS FOR MENISCAL SUTURE. IT WAS USED ANOTHER ONMISPAN IMPLANT TO FINISHED THE PROCEDURE WITH SUCCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284708 ↗
• MalfunctionJan 23, 2019Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE APPLICATOR ON THE OMNISPAN MENISCAL REPAIR, 0 DEG DEVICE DID NOT FIRE THE SECOND STITCH. IT WAS REPORTED THAT THE FIRST IMPLANT WAS LEFT IMPLANTED, NO PROBLEM RELATED TO THE FIRST FIRE. IT WAS NECESSARY TO OPEN A NEW SUTURE TO COMPLETE THE PROCEDURE. ACCORDING TO THE REPORTER, IN ORDER TO SOLVE THE PROBLEM, IT WAS NECESSARY TO OPEN NEW SUTURE. IT WAS REPORTED THAT WHEN CHANGING THE LOAD, THE SAME PROBLEM OCCURRED AND IT CONTINUED NOT FIRING THE SECOND POINT. IT WAS REPORTED THAT THE SURGEON HAD ENOUGH EXPERIENCE WITH HANDLING THE PRODUCT REQUESTED AUTHORIZATION TO SEND THE PRODUCT FOR ANALYSIS. THERE WAS NO HARM TO THE PATIENT AND THE SURGERY DID NOT EXCEED TIME LONGER THAN 30 MINUTES. IT WAS REPORTED THAT THE SAME LOCATION ON THE MENISCUS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8271299 ↗
• MalfunctionJan 16, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING MENSICAL REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN THE FIRST POINT OF THE SUTURE WAS PLACED, THE SUTURE FIRED PROPERLY AND WHEN SHOOTING WITH THE RED TRIGGER TO ADVANCE THE NEXT POINT, THE SECOND POINT OF THE SUTURE DID NOT ADVANCE. THERE WAS NO DELAY IN THE PROCEDURE WHICH WAS COMPLETED BY THE SURGEON USING ANOTHER DEVICE. THE NEEDLE WAS LOADED IN THE CORRECT ORIENTATION. THE SURGEON USED THE SAME LOCATION FOR THE SECOND IMPLANT. THE RED TRIGGER OF THE GUN DID NOT MOVE WHEN DEPRESSED AND THE THERE SURGERY GROUP DID HEAR A 'CLICK'. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8252299 ↗
• MalfunctionDec 13, 2018Positioning Failure; Positioning Failure

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN THE (B)(6) THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SECOND IMPLANTS FOR THE TWO 0 DEGREE OMNISPAN IMPLANTS WERE DEPLOYED WELL BUT AFTER FIRING IT TO ENGAGE THE CAPSULE, THEY WOULD NOT ENGAGE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8159575 ↗
• MalfunctionDec 13, 2018Positioning Failure; Positioning Failure

  ADDITIONAL EVENT INFORMATION RECEIVED ON 12/18/2018. IT WAS REPORTED BY AN AFFILIATE THAT THE PROCEDURE WAS COMPLETED TO 30 TO 40 MINUTES AND PROBE WAS USED DURING TENSIONING. THERE WAS 5 TO 10 MINUTES SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8159574 ↗
• MalfunctionNov 16, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE DEPLOYMENT GUN WAS ¿MISFIRING¿ AND WOULD NOT DEPLOY THE BACKSTOPS. THE PHYSICIAN USING THE PRODUCT WAS NOTED TO HAVE EXPERIENCE WITH THE PRODUCT. AFTER TWO IMPLANTS, A SECOND DEPLOYMENT GUN WAS OPENED AND THE DEVICE WORKED PROPERLY. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-54427 AND 1221934-2018-54428.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080717 ↗
• MalfunctionNov 16, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE DEPLOYMENT GUN WAS ¿MISFIRING¿ AND WOULD NOT DEPLOY THE BACKSTOPS. THE PHYSICIAN USING THE PRODUCT WAS NOTED TO HAVE EXPERIENCE WITH THE PRODUCT. AFTER TWO IMPLANTS, A SECOND DEPLOYMENT GUN WAS OPENED AND THE DEVICE WORKED PROPERLY. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-54427 AND 1221934-2018-54431.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080655 ↗
• MalfunctionNov 5, 2018Device-Device Incompatibility; Device-Device Incompatibility

  THE SALES REPRESENTATIVE REPORTED TWO OF THE CUSTOMER'S ANCHORS ON THEIR 0 DEGREE OMNISPAN NEEDLES DEPLOYED INTO THE MENISCUS AT THE SAME TIME DURING THE FIRST DEPLOYMENT DURING A MENISCAL PROCEDURE. HE STATED THE SURGEON PULLED THE GRAY TRIGGER ONCE AND BOTH ANCHORS DEPLOYED INTO THE MENISCUS. SHE REMOVED THE SUTURES BUT KEPT THE ANCHORS IN THE MENISCUS. THEY LOADED THE OMNISPAN APPLIER AGAIN WITH THE SECOND 0 DEGREE NEEDLE AND AGAIN THE SURGEON PULLED THE GRAY TRIGGER ONCE AND BOTH ANCHORS DEPLOYED INTO THE MENISCUS. SHE AGAIN CUT THE SUTURES BUT LEFT THE ANCHORS IN THE MENISCUS. TO COMPLETE THE PROCEDURE THEY LOADED THE OMNISPAN APPLIER A THIRD TIME AND HAD NO FURTHER ISSUES AT THAT POINT. THERE WERE NO PATIENT CONSEQUENCES, THIS DELAYED THE CASE BY TEN (10) MINUTES, AND BOTH NEEDLES WERE DISCARDED. THE ANCHORS WERE NOT LEFT FLOATING IN THE JOINT SPACE, THEY WERE CONTAINED IN THE MENISCUS. NO FURTHER DETAILS WERE AVAILABLE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52959.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038301 ↗
• MalfunctionNov 5, 2018Device-Device Incompatibility; Device-Device Incompatibility

  THE SALES REPRESENTATIVE REPORTED TWO OF THE CUSTOMER'S ANCHORS ON THEIR 0 DEGREE OMNISPAN NEEDLES DEPLOYED INTO THE MENISCUS AT THE SAME TIME DURING THE FIRST DEPLOYMENT DURING A MENISCAL PROCEDURE. HE STATED THE SURGEON PULLED THE GRAY TRIGGER ONCE AND BOTH ANCHORS DEPLOYED INTO THE MENISCUS. SHE REMOVED THE SUTURES BUT KEPT THE ANCHORS IN THE MENISCUS. THEY LOADED THE OMNISPAN APPLIER AGAIN WITH THE SECOND 0 DEGREE NEEDLE AND AGAIN THE SURGEON PULLED THE GRAY TRIGGER ONCE AND BOTH ANCHORS DEPLOYED INTO THE MENISCUS. SHE AGAIN CUT THE SUTURES BUT LEFT THE ANCHORS IN THE MENISCUS. TO COMPLETE THE PROCEDURE THEY LOADED THE OMNISPAN APPLIER A THIRD TIME AND HAD NO FURTHER ISSUES AT THAT POINT. THERE WERE NO PATIENT CONSEQUENCES, THIS DELAYED THE CASE BY TEN (10) MINUTES, AND BOTH NEEDLES WERE DISCARDED. THE ANCHORS WERE NOT LEFT FLOATING IN THE JOINT SPACE, THEY WERE CONTAINED IN THE MENISCUS. NO FURTHER DETAILS WERE AVAILABLE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52963.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038265 ↗
• MalfunctionSep 3, 2018Positioning Failure; Positioning Failure

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, THE SURGEON OBSERVED THAT WHEN CONDUCTING THE IMPLANT PROCEDURE THE FIRST IMPLANT WORKED; HOWEVER, WHEN CONDUCTING THE SECOND HALF OF THE TWO IMPLANT SYSTEM THE SECOND IMPLANT PREMATURELY DEPLOYED. THE SALES REP REPORTED THAT THE SURGEON WAS ABLE TO REMOVE ALL PIECES FROM THE FIRST IMPLANT, AND COMPLETE THE PROCEDURE USING A LIKE DEVICE, WITH A 10 MINUTE DELAY AND NO PATIENT CONSEQUENCES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840906 ↗
• MalfunctionSep 3, 2018Positioning Failure; Positioning Failure

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, THE SURGEON OBSERVED THAT WHEN CONDUCTING THE IMPLANT PROCEDURE THE FIRST IMPLANT WORKED; HOWEVER, WHEN CONDUCTING THE SECOND HALF OF THE TWO IMPLANT SYSTEM THE SECOND IMPLANT PREMATURELY DEPLOYED. THE SALES REP REPORTED THAT THE SURGEON WAS ABLE TO REMOVE ALL PIECES FROM THE FIRST IMPLANT, AND COMPLETE THE PROCEDURE USING A LIKE DEVICE, WITH A 10 MINUTE DELAY AND NO PATIENT CONSEQUENCES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840867 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092836, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723