ORTHOCORD 223115Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705008858), received between Jul 10, 2018 and Jul 10, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K040004); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED BROKEN ORTHOCORD SUTURES DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE. HE STATED THE IT WAS FIVE (5) SUTURES TOTAL THAT BROKE. ALL OF THE SUTURES BROKE AFTER THE ANCHOR WAS INSERTED AND THE SURGEON WAS PULLING SUTURES TO TEST STRENGTH. THESE SUTURES CAME IN PACKS OF TWO (2) SO THEY WENT THROUGH THREE (3) PACKS OF SUTURES. THE SURGEON ENDED UP USING FIBERWIRE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THERE WAS A THIRTY (30) MINUTE DELAY. THE SALES REPRESENTATIVE STATED IT WAS A (B)(6) MALE WITH GOOD BONE QUALITY. THIS WAS NOT A REVISION SURGERY. NO FURTHER INFORMATION COULD BE PROVIDED. THESE SUTURES COME IN A BOX OF TWELVE (12), THE CUSTOMER IS RETURNING THE REMAINING PACKS OF SUTURES OF THIS LOT THEY HAVE FOR EVALUATION AND AS A COURTESY WE REPLACED THE WHOLE BOX FOR THE CUSTOMER. PLEASE SEE ALSO MEDWATCH REPORTS 1221934-2018-51217 AND 1221934-2018-51219.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673726 ↗
• MalfunctionJul 10, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED BROKEN ORTHOCORD SUTURES DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE. HE STATED THE IT WAS FIVE (5) SUTURES TOTAL THAT BROKE. ALL OF THE SUTURES BROKE AFTER THE ANCHOR WAS INSERTED AND THE SURGEON WAS PULLING SUTURES TO TEST STRENGTH. THESE SUTURES CAME IN PACKS OF TWO (2) SO THEY WENT THROUGH THREE (3) PACKS OF SUTURES. THE SURGEON ENDED UP USING FIBERWIRE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THERE WAS A THIRTY (30) MINUTE DELAY. THE SALES REPRESENTATIVE STATED IT WAS A (B)(6) MALE WITH GOOD BONE QUALITY. THIS WAS NOT A REVISION SURGERY. NO FURTHER INFORMATION COULD BE PROVIDED. THESE SUTURES COME IN A BOX OF TWELVE (12), THE CUSTOMER IS RETURNING THE REMAINING PACKS OF SUTURES OF THIS LOT THEY HAVE FOR EVALUATION AND AS A COURTESY WE REPLACED THE WHOLE BOX FOR THE CUSTOMER. PLEASE SEE ALSO MEDWATCH REPORTS 1221934-2018-51217 AND 1221934-2018-51220.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673714 ↗
• MalfunctionJul 10, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED BROKEN ORTHOCORD SUTURES DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE. HE STATED THE IT WAS FIVE (5) SUTURES TOTAL THAT BROKE. ALL OF THE SUTURES BROKE AFTER THE ANCHOR WAS INSERTED AND THE SURGEON WAS PULLING SUTURES TO TEST STRENGTH. THESE SUTURES CAME IN PACKS OF TWO (2) SO THEY WENT THROUGH THREE (3) PACKS OF SUTURES. THE SURGEON ENDED UP USING FIBERWIRE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THERE WAS A THIRTY (30) MINUTE DELAY. THE SALES REPRESENTATIVE STATED IT WAS A (B)(6) MALE WITH GOOD BONE QUALITY. THIS WAS NOT A REVISION SURGERY. NO FURTHER INFORMATION COULD BE PROVIDED. THESE SUTURES COME IN A BOX OF TWELVE (12), THE CUSTOMER IS RETURNING THE REMAINING PACKS OF SUTURES OF THIS LOT THEY HAVE FOR EVALUATION AND AS A COURTESY WE REPLACED THE WHOLE BOX FOR THE CUSTOMER. PLEASE SEE ALSO MEDWATCH REPORTS 1221934-2018-51219 AND 1221934-2018-51220.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673690 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040004. One submission often covers many models, so check the product and lot details in each record.

• Z-1316-2009 · Feb 2, 2009 · Terminated
  Orthocord Suture, DePuy Mitek, a Johnson & Johnson Company; . DePuy Mitek, Inc. 325 Paramount Drive, Raynham, MA 02767 Sutures are intended for general soft tissue approximation a