MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK SWI-VELOCK,3.5X 15.8MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH,PEEK SWI-VELOCK,3.5X 15.8MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by an arthrex employee via email that an ar-2325pslc swivelock broke when being implanted.This was discovered during ankle ligament repair and internal fixation procedure on (b)(6) 2021.When surgeon used a hammer to insert the peek implant, it broke inside the patient.Surgeon used a new swivelock device from a different lot number to complete procedure.Additional information requested.
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
Complaint not confirmed, the device was returned without the anchor or eyelet.No abnormalities observed.

• Brand Name: SUTR ANCH,PEEK SWI-VELOCK,3.5X 15.8MM
• 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: 12983920
• Report Number: 1220246-2021-04089
• Device Sequence Number: 4432030
• Product Code: MAI
• UDI-Device Identifier: 00888867026971
• UDI-Public: 00888867026971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101823
• 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
• Report Date (Section B): 01/21/2022

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: 03/31/2026
• Device Model Number: SUTR ANCH,PEEK SWI-VELOCK,3.5X 15.8MM
• Device Catalogue Number: AR-2325PSLC
• Device Lot Number: 13102546
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown