MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222304
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device is not being returned, it was discarded, therefore unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo, it could be observed that the anchor is in used condition, it is not seated in its corresponding place.Residues of biological matter could be seen on the suture, the anchor and the handle.A manufacturing record evaluation was performed for the finished device 9l45425 number, and no non-conformances were identified.  as part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.  according with the visual inspection result, this complaint can be confirmed.A possible root cause can be attributed to a procedural variables, such handling of the device or product interaction during procedure.However, it cannot be conclusively determined.As per ifu: bone stock must be adequate to allow proper and secure anchor placement.Incomplete insertion or poor bone quality may result in anchor pullout.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by a healthcare professional in china that during a shoulder repair procedure on (b)(6) 2023, it was observed that the anchor pulled out upon tightening the suture on the 4.5 healix advance peek 3-suture anchor w/ orthocord device.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.

• Brand Name: 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16478800
• Report Number: 1221934-2023-00986
• Device Sequence Number: 14252816
• Product Code: HWC
• UDI-Device Identifier: 10886705021406
• UDI-Public: 10886705021406
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Expiration Date: 05/31/2025
• Device Model Number: 222304
• Device Catalogue Number: 222304
• Device Lot Number: 9L45425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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