MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
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
3 anchors broke upon insertion and incorrect advice during use.There was a 30 minutes delay to the scapholunate ligament reconstruction procedure.Additional anesthesia is required patient outcome was good.

• Brand Name: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, 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: 14675323
• Report Number: 1220246-2022-05073
• Device Sequence Number: 12456927
• Product Code: MBI
• UDI-Device Identifier: 00888867287105
• UDI-Public: 00888867287105
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Device Catalogue Number: AR-8978P-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown