MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH HIP PEEK P-LCK 2.9X12.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH HIP PEEK P-LCK 2.9X12.5MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 11/23/2023, it was reported by an arthrex subsidiary employee via (b)(4), that an ar-2923phs suture anchor peek hip pushlock anchor backed out.This occurred during a hip arthroscopy procedure on 11/08/2023 the material was safely removed and reassembled with the correct position and used to successfully complete the case.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was provided on 1/3/2024 where the arthrex subsidiary employee stated the guide was used accompanied by a drill bit to prepare the bone.The patient's bone quality was good.The implant was dismantled and all the remains of material that remained were recovered, without leaving anything inside the case.

• Brand Name: SUTR ANCH HIP PEEK P-LCK 2.9X12.5MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18369037
• Report Number: 1220246-2023-09541
• Device Sequence Number: 7805903
• Product Code: MAI
• UDI-Device Identifier: 00888867195837
• UDI-Public: 00888867195837
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2024

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 Model Number: SUTR ANCH HIP PEEK P-LCK 2.9X12.5MM
• Device Catalogue Number: AR-2923PHS
• Device Lot Number: 14983332
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 10/11/2024; 01/03/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 10/28/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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