GII QUICKANCHOR PANACRYL 212134Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886705001989), received between Jul 9, 2018 and Oct 3, 2020 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2020Break; Break

  DURING A PROCEDURE FOR AN ELBOW FRACTURE, THE SURGEON (WHO IS EXPERIMENTED) USED THE DEVICE, MADE A FIRST KNOT AND TIGHT IT WITHOUT ANY PROBLEM. AT THE SECOND KNOT, THE THREAD BROKE. NO PATIENT CONSEQUENCE. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. DELAY OF FEW MINUTES.

  Patient problems: Not Applicable

  MAUDE report 10624237 ↗
• MalfunctionJan 15, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA EMAIL, THAT DURING AN UNKNOWN PROCEDURE, AND WHILE USING A GII QA+ W #2 PANACRYL, THE SUTURE BROKE WHEN APPLYING TENSION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER ANCHOR. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

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

  MAUDE report 9592066 ↗
• MalfunctionDec 20, 2019Break; Break

  THIS IS REPORT 2 OF 6 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SIX ANCHORS ON SUTURE THE GII QA+ #2 PAN CP-2 *EA DEVICE BROKE. THERE WAS A DELAY OF 10 - 15 MINUTES 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: Not Applicable

  MAUDE report 9505899 ↗
• MalfunctionDec 20, 2019Break; Break

  THIS IS REPORT 5 OF 6 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SIX ANCHORS ON SUTURE THE GII QA+ #2 PAN CP-2 EA DEVICE BROKE. THERE WAS A DELAY OF 10-15 MINUTES 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: Not Applicable

  MAUDE report 9505888 ↗
• MalfunctionDec 20, 2019Break; Break

  THIS IS REPORT 6 OF 6 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SIX ANCHORS ON SUTURE THE GII QA+ #2 PAN CP-2 *EA DEVICE BROKE. THERE WAS A DELAY OF 10 - 15 MINUTES 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: Not Applicable

  MAUDE report 9505864 ↗
• MalfunctionDec 20, 2019Break; Break

  THIS IS REPORT 4 OF 6 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SIX ANCHORS ON SUTURE THE GII QA+ #2 PAN CP-2 *EA DEVICE BROKE. THERE WAS A DELAY OF 10 - 15 MINUTES 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: Not Applicable

  MAUDE report 9505863 ↗
• MalfunctionDec 20, 2019Break; Break

  THIS IS REPORT 3 OF 6 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SIX ANCHORS ON SUTURE THE GII QA+ #2 PAN CP-2 EA DEVICE BROKE. THERE WAS A DELAY OF 10-15 MINUTES 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: Not Applicable

  MAUDE report 9505846 ↗
• MalfunctionDec 20, 2019Break; Break

  THIS IS REPORT 1 OF 6 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SIX ANCHORS ON SUTURE THE GII QA+ #2 PAN CP-2 *EA DEVICE BROKE. THERE WAS A DELAY OF 10 - 15 MINUTES 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: Not Applicable

  MAUDE report 9505844 ↗
• InjuryJan 3, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER ARTHROSOCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GII QA+ #2 PAN CP-2 EA BROKE UPON REMOVAL THAT PART OF IT WAS STILL IN THE PATIENT. THE PROCEDURE INVOLVED WAS SHOULDER ARTHROSCOPY AND THE PRODUCT WAS GII QA+ #2 PANACRYL. 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 8212324 ↗
• MalfunctionNov 9, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE ANCHOR WAS INSERTED INTO BONE WITHOUT COMPLICATION; WHEN SURGEON PULLED AT THE SUTURE TO CHECK THE FIT OF THE ANCHOR, THE SUTURE RUPTURED. THE SURGEON WANTED TO RE-FIXATE WITH THREE ANCHORS. TWO ANCHORS RUPTURE AT THE SUTURE, SO HE HAD TO USE FIVE ANCHORS TO FINISH THE PROCEDURE. THERE WAS A TWENTY (20) MINUTE SURGICAL DELAY. THE SURGEON STATED THAT HE DID NOT PULL EXCESSIVELY. THE DATE OF THE PROCEDURE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8055356 ↗
• MalfunctionAug 24, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE GII QUICK ANCHOR PLUS W/ #2 PANACRYL DEVICE BROKE WHILE TYING THE KNOT. ACCORDING TO THE REPORT, THE EVENT OCCURRED AT THE END OF THE SURGERY. IT WAS REPORTED THAT THE SURGEON USED AN ARTHREX ANCHOR TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL 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 7814261 ↗
• MalfunctionAug 24, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE GII QUICK ANCHOR PLUS W/ #2 PANACRYL DEVICE BROKE WHILE TYING THE KNOT. ACCORDING TO THE REPORT, THE EVENT OCCURRED AT THE END OF THE SURGERY. IT WAS REPORTED THAT THE SURGEON USED AN ARTHREX ANCHOR TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL 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 7814256 ↗
• MalfunctionAug 24, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE GII QUICK ANCHOR PLUS W/ #2 PANACRYL DEVICE BROKE WHILE TYING THE KNOT. ACCORDING TO THE REPORT, THE EVENT OCCURRED AT THE END OF THE SURGERY. IT WAS REPORTED THAT THE SURGEON USED AN ARTHREX ANCHOR TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL 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 7814248 ↗
• MalfunctionAug 24, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE GII QUICK ANCHOR PLUS W/ #2 PANACRYL DEVICE BROKE WHILE TYING THE KNOT. ACCORDING TO THE REPORT, THE EVENT OCCURRED AT THE END OF THE SURGERY. IT WAS REPORTED THAT THE SURGEON USED AN ARTHREX ANCHOR TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL 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 7814244 ↗
• MalfunctionAug 24, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE GII QUICK ANCHOR PLUS W/ #2 PANACRYL DEVICE BROKE WHILE TYING THE KNOT. ACCORDING TO THE REPORT, THE EVENT OCCURRED AT THE END OF THE SURGERY. IT WAS REPORTED THAT THE SURGEON USED AN ARTHREX ANCHOR TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL 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 7814243 ↗
• MalfunctionAug 24, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE GII QUICK ANCHOR PLUS W/ #2 PANACRYL DEVICE BROKE WHILE TYING THE KNOT. ACCORDING TO THE REPORT, THE EVENT OCCURRED AT THE END OF THE SURGERY. IT WAS REPORTED THAT THE SURGEON USED AN ARTHREX ANCHOR TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL 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 7814235 ↗
• MalfunctionAug 24, 2018Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE GII QUICK ANCHOR PLUS W/ #2 PANACRYL DEVICE BROKE WHILE TYING THE KNOT. ACCORDING TO THE REPORT, THE EVENT OCCURRED AT THE END OF THE SURGERY. IT WAS REPORTED THAT THE SURGEON USED AN ARTHREX ANCHOR TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL 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 7814225 ↗
• MalfunctionAug 24, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AT THE END OF THE SURGERY, DURING SHOULDER REPAIR, IT WAS OBSERVED THAT THE ORTHOCORD SUTURE BROKE IN TWO PIECES WHILE TYING THE KNOTS. IT WAS REPORTED THAT THERE SEEMED A QUALITY ISSUE OF THE ORTHOCORD SUTURE. THEY USED AN ANCHOR FROM A COMPETITOR WITHOUT ANY FURTHER ISSUES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL 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 7812949 ↗
• MalfunctionAug 23, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE SUTURE BURST AFTER THE ANCHOR WAS INSERTED DURING AN UNSPECIFIED SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGERY WAS FINISHED WITH A SAME LIKE PRODUCT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL 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 7808752 ↗
• MalfunctionJul 17, 2018Break; Break

  SHOULDER ARTHROSCOPY, (B)(6) 2018. IT WAS REPORTED THAT DURING THE SURGERY THE ANCHORS WERE USED FOR A FIXATION OF THE LIGAMENTUM PATELLAE. WHEN THE SURGEON WANTED TO TIE THE SUTURES, THEY BROKE. IT HAPPENED TO 5 ANCHORS. DESCRIBE THE 'DAMAGE' OR 'OTHER' OUTCOME -THE SURGERY TOOK LONGER BECAUSE THEY HAD TO OPEN A LOT OF NEW ANCHORS. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE ? NEW ANCHORS OPENED . HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE(MINUTES)? 30 MINUTES. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695462 ↗
• MalfunctionJul 17, 2018Break; Break

  SHOULDER ARTHROSCOPY, (B)(6) 2018. IT WAS REPORTED THAT DURING THE SURGERY THE ANCHORS WERE USED FOR A FIXATION OF THE LIGAMENTUM PATELLAE. WHEN THE SURGEON WANTED TO TIE THE SUTURES, THEY BROKE. IT HAPPENED TO 5 ANCHORS. DESCRIBE THE 'DAMAGE' OR 'OTHER' OUTCOME -THE SURGERY TOOK LONGER BECAUSE THEY HAD TO OPEN A LOT OF NEW ANCHORS. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE ? NEW ANCHORS OPENED. HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE(MINUTES)? 30 MINUTES. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695451 ↗
• MalfunctionJul 17, 2018Break; Break

  SHOULDER ARTHROSCOPY, (B)(6) 2018, IT WAS REPORTED THAT DURING THE SURGERY THE ANCHORS WERE USED FOR A FIXATION OF THE LIGAMENTUM PATELLAE. WHEN THE SURGEON WANTED TO TIE THE SUTURES, THEY BROKE. IT HAPPENED TO 5 ANCHORS. DESCRIBE THE 'DAMAGE' OR 'OTHER' OUTCOME - THE SURGERY TOOK LONGER BECAUSE THEY HAD TO OPEN A LOT OF NEW ANCHORS. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE ? NEW ANCHORS OPENED. HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE(MINUTES)? 30 MINUTES. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695448 ↗
• MalfunctionJul 17, 2018Break; Break

  SHOULDER ARTHROSCOPY- (B)(6) 2018. IT WAS REPORTED THAT DURING THE SURGERY THE ANCHORS WERE USED FOR A FIXATION OF THE LIGAMENTUM PATELLAE. WHEN THE SURGEON WANTED TO TIE THE SUTURES, THEY BROKE. IT HAPPENED TO 5 ANCHORS. DESCRIBE THE 'DAMAGE' OR 'OTHER' OUTCOME -THE SURGERY TOOK LONGER BECAUSE THEY HAD TO OPEN A LOT OF NEW ANCHORS. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE ? NEW ANCHORS OPENED. HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE(MINUTES)? 30 MINUTES. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695440 ↗
• MalfunctionJul 17, 2018Break; Break

  SHOULDER ARTHROSCOPY (B)(6) 2018. IT WAS REPORTED THAT DURING THE SURGERY THE ANCHORS WERE USED FOR A FIXATION OF THE LIGAMENTUM PATELLAE. WHEN THE SURGEON WANTED TO TIE THE SUTURES, THEY BROKE. IT HAPPENED TO 5 ANCHORS. DESCRIBE THE 'DAMAGE' OR 'OTHER' OUTCOME -THE SURGERY TOOK LONGER BECAUSE THEY HAD TO OPEN A LOT OF NEW ANCHORS. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE ? NEW ANCHORS OPENED. HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE(MINUTES)? 30 MINUTES. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695436 ↗
• MalfunctionJul 13, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE FROM (B)(6) THAT AT THE END OF AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ORTHOCORD SUTURE BROKE IN TWO PIECES WHILE TYING THE KNOTS. ACCORDING TO THE REPORT, THERE SEEMS TO BE A QUALITY ISSUE OF THE ORTHOCORD SUTURE. THEY USED AN ANCHOR FROM A COMPETITOR WITHOUT ANY FURTHER ISSUES. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL 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 7686734 ↗