MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK, 3.9X17.9MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	PEEK SWIVELOCK, 3.9X17.9MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/03/2023
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 5/4/2023, it was reported by a sales representative via phone that an ar-2326pslc peek swivelock was being inserted in the bone socket when the sutures let go of the tendon.The surgeon opted out of a bicep tenodesis repair and completed the case as a tenotomy on (b)(6) 2023.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in h3, h6: type of investigation, investigation findings, investigation conclusions, and h10, and updated information in g1, g3.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the reported event is not confirmed without the device being returned or any photo provided.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: PEEK SWIVELOCK, 3.9X17.9MM
• 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: jared engle ; 8009337001
• MDR Report Key: 17011601
• Report Number: 1220246-2023-06792
• Device Sequence Number: 15362827
• Product Code: MAI
• UDI-Device Identifier: 00888867289154
• UDI-Public: 00888867289154
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PEEK SWIVELOCK, 3.9X17.9MM
• Device Catalogue Number: AR-2326PSLC
• Device Lot Number: 15027690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown