NA 214710Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886705004416), received between Jun 19, 2018 and Oct 22, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (6 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE VERSALOK DEPLOYMENT GUN DEVICE WAS FAULTY AND THE ANCHOR DID NOT DEPLOY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360555 ↗
• MalfunctionAug 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT ON AN UNKNOWN DATE IT WAS OBSERVED THAT THE DEPLOYMENT GUN DEVICE COULD NOT FIRE SUCCESSFULLY WHEN PLACING A VERSALOK ANCHOR. 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 19916611 ↗
• MalfunctionJul 16, 2024Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED FROM JAPAN DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE VERSALOK DEPLOYMENT GUN DEVICE COULD NOT BE LOCKED AND CAME OFF WITHOUT DEPLOYING THE VERSALOK THREADER TAB DEVICE UPON INSERTION INTO THE GREATER TUBEROSITY OF THE HUMERUS. THEREFORE, THE IMPLANT WAS NOT IMPLANTED. IT WAS REPORTED THAT A TOTAL OF FOUR IMPLANTS WERE USED BUT ALL DID NOT DEPLOY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751185 ↗
• MalfunctionJun 20, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023. IT WAS OBSERVED THAT THE LOT NUMBER PRINTED ON THE OUTSIDE PACKAGING OF THE DEPLOYMENT GUN DEVICE DID NOT MATCH THE LOT NUMBER PRINTED ON THE ACTUAL DEVICE ITSELF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17162791 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE DEPLOYMENT GUN DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED MINIMAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17033145 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE THE DEPLOYMENT GUN DEVICE WOULD NOT PROPERLY DEPLOY ANCHOR; AND THAT SOME MECHANISM WAS BROKEN IN THE LOCK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 16593089 ↗
• MalfunctionDec 23, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE DEPLOYMENT GUN DEVICE WAS SUSPECTED TO HAVE AN AXIS DISTORTION. DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16044581 ↗
• MalfunctionMay 10, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TENSION WHEEL ON THE VERSALOK DEPLOYMENT GUN DEVICE NO LONGER TENSIONED THE SUTURE AFTER THE ANCHOR WAS ALREADY DEPLOYED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TENSION WHEEL WAS RUNNING FREELY DUE TO THE LOCKING MECHANISM BEING LOOSE. THERE AS NOT SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11799197 ↗
• MalfunctionNov 11, 2020Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEPLOYMENT GUN DEVICE GOT STUCK TO THE INSERTER OF THE VERSALOK; AND COULD NOT BE REMOVED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DRIVER SHAFT WAS JAMMED AND ITS DISTAL PART WAS BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10823392 ↗
• MalfunctionAug 13, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR THE TRIGGER OF THE DEPLOYMENT GUN COMPLETELY BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10402875 ↗
• MalfunctionMay 26, 2020Material Frayed; Material Frayed

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE DEPLOYMENT GUN CUTTED THE SUTURE UPON TENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10087803 ↗
• MalfunctionApr 22, 2020Corroded; Corroded

  IT WAS REPORTED BY AFFILIATE VIA EMAIL, THAT DURING A ROTATOR CUFF REPAIR, A DEPLOYMENT GUN FAILED TO TENSION SUTURES ENOUGH TO TENSION ANCHOR. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WAS A SURGICAL DELAY OF 3-4 MINUTES. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE SURGICAL DELAY DID NOT HAVE A PATIENT OR USER IMPACT. IT WAS ALSO REPORTED THE CASE WAS COMPLETED WITH AN ALTERNATIVE READILY AVAILABLE DEVICE. ADDITIONAL SURGICAL INTERVENTION IS NOT PLANNED OR REQUIRED.

  Patient problems: Not Applicable

  MAUDE report 9988630 ↗
• MalfunctionApr 9, 2020Corroded; Corroded

  IT WAS REPORTED BY AFFILIATE VIA EMAIL, THAT DURING A ROTATOR CUFF REPAIR, A DEPLOYMENT GUN FAILED TO FULLY TENSION THE SUTURES ON ANCHOR ENGAGEMENT, SUTURES HAD TO BE TENSIONED BY HAND TO CONTINUE WITH PROCEDURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED A MINUTE DELAY WITH NO IMPACT TO THE PATIENT OR USER. THE AFFILIATE REPORTED THE SUTURE HAD TO TENSIONED BY HAND AND THE CASE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946411 ↗
• MalfunctionDec 11, 2019Positioning Failure; Loose or Intermittent Connection; Positioning Failure; Loose or Intermittent Connection

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THEIR VERSALOK DEPLOYMENT GUN WOULD NOT ENGAGE THE IMPLANT ON THE DELIVERY ROD. THE SALES REP STATED THAT THE DEVICE WOULD NOT LOCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451237 ↗
• MalfunctionSep 16, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT WHEN THE SURGEON ATTACHED THE ANCHOR TO THE GUN, THE SURGEON FELT LOOSENING BETWEEN THE DEVICES SLIGHTLY. THE SURGEON STOPPED USING THE ANCHOR AND ANOTHER VERSALOK ANCHOR WAS USED TO COMPLETE THE SURGERY. IT WAS FURTHER REPORTED THAT THE VERSALOK GUN WAS IN THE LOCKED POSITION WHEN CONNECTED TO THE INSERTER SHAFT OF THE ANCHOR. IT WAS UNKNOWN IF THE INSERTER SHAFT OF THE ANCHOR AND VERSALOK GUN CLICKED FIRMLY INTO PLACE WHEN CONNECTED. IT WAS ALSO UNKNOWN IF THE SURGEON WAS MANUALLY TENSIONING SUTURES OR USING THE TENSIONING WHEEL OF THE VERSALOK GUN. THE SAME VERSALOK GUN WAS USED WITH ANOTHER VERSALOK ANCHOR TO COMPLETE THE CASE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9070023 ↗
• MalfunctionFeb 19, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THE ANCHOR HAS BLOCKED WIRES BUT DID NOT DEPLOYED: NO HOLDING IN BONE. OBLIGATION TO CUT THE SUTURES AND REMOVE 1 OF THE 2 ANCHORS. REPAIR SINGLE INSTEAD OF DOUBLE ROW. 1 ON 2 REMAINED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351880 ↗
• MalfunctionNov 26, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A DEMONSTRATION, IT WAS OBSERVED THAT THE VERSALOK DEPLOYMENT GUN DEVICE DID NOT FIRE. ACCORDING TO THE REPORTER, THE COLOR OF THE GUN WAS GRAY AND THERE WERE FOUR TOTAL SUTURES. THERE WAS NO CASE INVOLVED, THEREFORE NO PATIENT INVOLVEMENT OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE. THE DEVICE IS BEING RETURNED FOR EVALUATION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF 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: Not Applicable

  MAUDE report 8103463 ↗
• MalfunctionOct 30, 2018Break; Break

  IT WAS REPORTED THAT DURING ARCR THE SURGEON FOUND THE ANCHOR WAS NOT DEPLOYED BY THE DELIVERY GUN AFTER THE INSERTER OF THE DEVICE WAS REMOVED. THE SURGEON PUT THE INSERTER BACK AND TRIED TO DEPLOY IT AGAIN, BUT THE ANCHOR WAS BROKEN WHEN IT WAS DEPLOYED UP TO THE MIDDLE OF THE BONE HOLE. THE SURGEON REMOVED THE ANCHOR AND USED A BACKUP DEVICE TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT NO BROKEN PIECE WAS LEFT IN THE PATIENT¿S BODY. THE SURGEON SUCCEEDED IN FIXING ANCHORS AFTER THIS INCIDENT. THERE WAS NO HARM TO THE PATIENT. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51489.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8020422 ↗
• MalfunctionOct 17, 2018Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE SUTURE ANCHOR DID NOT DEPLOY FROM THEIR VERSALOC GUN DURING A ROTATOR CUFF REPAIR. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE CASE WAS COMPLETED WITH A COMPETITORS DEVICE. NO NEW BONE HOLES NEEDED TO BE CREATED. THE DEVICE IS BEING RETURNED. 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 7973404 ↗
• MalfunctionAug 20, 2018Positioning Failure; Positioning Failure

  THE SALES REP REPORTED THAT DURING A DEMONSTRATION OF HIS VERSALOK DEPLOYMENT GUN THE 1ST DEPLOYMENT WOULD NOT FIRE. THE DEVICE WAS NOT USED IN A PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE SALES REP VERIFIED THE DEVICE IS 4 YEARS OLD, HAS SEEN HEAVY USE, AND WAS VISIBLY WORN. THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800138 ↗
• MalfunctionJul 17, 2018Separation Problem; Separation Problem

  OUR AFFILIATE REPORTED THE GUN WAS IN THE LOCKED POSITION, HOWEVER, THE SURGEON WAS NOT ABLE TO DEPLOY THE ANCHOR PIN INTO THE SLEEVE BY SQUEEZING THE TRIGGER. HE ALSO TESTED THE GUN AGAIN BY USING ANOTHER ANCHOR WITH THE SAME RESULT. THE SURGEON FINISHED THE PROCEDURE WITH A PUSHLOCK ANCHOR. NO PATIENT HARM REPORTED. ADDIT INFO THE DEVICE IS BEING DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7692941 ↗
• MalfunctionJun 19, 2018Positioning Failure; Positioning Failure

  OUR AFFILIATE REPORTED WHEN THAT WHEN TRIGGER WAS PULLED, THE GUN DID NOT FUNCTION PROPERLY DUE TO A LOOSENED SCREW. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFFILIATE STATED PROCEDURE TIME WAS EXTENDED THIRTY (30) MINUTES. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50757.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7612870 ↗