MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX PEEK ANCH.W/OCORD; SCREW, FIXATION, BONE

Catalog Number	222205
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: a photo was provided to depuy synthes for review.Visual inspection of the returned photo found that the anchor was detached from the inserter.The inserter tip was broken at the distal end.No other anomalies were noted.The overall complaint was confirmed as the observed condition of 4.5 healix advance br w/ocord would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.The possible root cause can be associated with off axis insertion and levering during insertion.As per ifu, do not apply a bending force to the inserter.This can damage the anchor or inserter tip, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Document specification review: ifu, according to the information received, it was reported that before the surgery, opened the packing(did not use), noted the shaft was broken off(as the attached photo shows).No additional information could be provided.The product was returned to depuy synthes for evaluation.Visual inspection found that the device had the anchor and the inserter tip broken and detached from the inserter.The anchor had foreign matter, presumably biological substance.No other anomalies were noted.As the device showed signs of use, the reported complaint of failure without use cannot be confirmed.The overall complaint was confirmed as the observed condition of 4.5 healix advance br w/ocord would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.The possible root cause can be associated with off axis insertion and levering during insertion.As per ifu, do not apply a bending force to the inserter.This can damage the anchor or inserter tip, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.There was no non-conformance regarding this lot.
Event or Problem Description
It was reported that during service and evaluation, it was determined that the 4.5 healix peek anch.W/ocord device was fractured (broken in two pieces).It was reported in the service order that the device shaft was broken off while still in the package prior to a rotator cuff repair procedure.Another device was used to complete the surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.

• Brand Name: 4.5 HEALIX PEEK ANCH.W/OCORD
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle CH-02 400; SZ CH-02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24144419
• Report Number: 1221934-2026-00319
• Device Sequence Number: 9487140
• Product Code: HWC
• UDI-Device Identifier: 10886705007530
• UDI-Public: (01)10886705007530(10)104QTT(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 222205
• Device Lot Number: 104QTT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown