MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 12/29/2022 by a sales representative via email that an ar-2923bch suture anchor eyelet broke and would not contain the sutures.Case involvement, device broke during use.Per facility: "during a labral repair of the hip the labral tapes were passed around the labrum and the pilot hole was drilled with a 2923dhs.The suture was put through the eyelet of the 2.9 pushlock and introduced into the hip.The eyelet was put into the pilot hole and the slack was pulled out of the suture and the eyelet popped off the anchor.When the eyelet and anchor were removed from the hip we noticed there was a slit in the plastic eyelet and the sutures wouldn't stay in any longer.".
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.
Additional Manufacturer Narrative
Since the complaint device was not returned, a physical evaluation of the device was not performed.However, without the device being returned or any photos provided, the complaint allegation is not confirmed.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16173458
• Report Number: 1220246-2023-06121
• Device Sequence Number: 4370043
• Product Code: MAI
• UDI-Device Identifier: 00888867195844
• UDI-Public: 00888867195844
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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 Expiration Date: 09/30/2024
• Device Model Number: SUTR ANCH HIP BIO-COMP P-LCK 2.9X12.5MM
• Device Catalogue Number: AR-2923BCH
• Device Lot Number: 15007407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown