FASTIN ORTHOCORD 222992Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705008704), received between Mar 19, 2020 and Mar 19, 2020 — classified as 3 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K041075, K060664); 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.

• MalfunctionMar 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED BY EMPLOYEE VIA COMPLAINT SUBMISSION TOOL THAT DURING TRICEPS REPAIR, THE FASTIN RC 6.5 W/OCORD W/NDLS STRIPPED OFF THE ANCHOR BEFORE ANCHOR WAS FULLY INSERTED, A SECOND IMPLANT WAS OPENED TO UTILIZE THE INSERTER TO CONTINUE DRIVING THE IMPLANT, THE INSERTER STRIPPED AGAIN, A THIRD IMPLANT WAS OPENED AND THEN TRY WITH THE INSERTER, THE ANCHOR WAS EXPLANTED AND ANOTHER IMPLANT WAS INSERTED. NO PATIENT CONSEQUENCES, THERE WAS A SURGICAL DELAY OF 30 MINUTES REPORTED. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9854224 ↗
• MalfunctionMar 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED BY EMPLOYEE VIA COMPLAINT SUBMISSION TOOL THAT DURING TRICEPS REPAIR, THE FASTIN RC 6.5 W/OCORD W/NDLS STRIPPED OFF THE ANCHOR BEFORE ANCHOR WAS FULLY INSERTED, A SECOND IMPLANT WAS OPENED TO UTILIZE THE INSERTER TO CONTINUE DRIVING THE IMPLANT, THE INSERTER STRIPPED AGAIN, A THIRD IMPLANT WAS OPENED AND THEN TRY WITH THE INSERTER, THE ANCHOR WAS EXPLANTED AND ANOTHER IMPLANT WAS INSERTED. NO PATIENT CONSEQUENCES, THERE WAS A SURGICAL DELAY OF 30 MINUTES REPORTED. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9853523 ↗
• MalfunctionMar 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED BY EMPLOYEE VIA COMPLAINT SUBMISSION TOOL THAT DURING TRICEPS REPAIR, THE FASTIN RC 6.5 W/OCORD W/NDLS STRIPPED OFF THE ANCHOR BEFORE ANCHOR WAS FULLY INSERTED, A SECOND IMPLANT WAS OPENED TO UTILIZE THE INSERTER TO CONTINUE DRIVING THE IMPLANT, THE INSERTER STRIPPED AGAIN, A THIRD IMPLANT WAS OPENED AND THEN TRY WITH THE INSERTER, THE ANCHOR WAS EXPLANTED AND ANOTHER IMPLANT WAS INSERTED. NO PATIENT CONSEQUENCES, THERE WAS A SURGICAL DELAY OF 30 MINUTES REPORTED. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9853143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041075, K060664. One submission often covers many models, so check the product and lot details in each record.

• Z-0446-06 · Oct 27, 2005 · Terminated
  Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740