MAUDE Adverse Event Report: ARTHREX, INC. PASSER, CERCLAGE WIRE, BENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	PASSER, CERCLAGE WIRE, BENT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that the ar-5050-10 guide wire passer is broken in half.This was discovered during use in a procedure.
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 confirmed.One unpackaged ar-5050-10 was received for investigation.Visual inspection identified that the curved shaft of the returned ar-5050-10 had broken from the handle at the weld.No further breakage was present.Dimensional analysis of the shaft width proximal to the weld using digital micrometer id: 224 concluded that the device met design specifications.The cause remains undetermined.

• Brand Name: PASSER, CERCLAGE WIRE, BENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13472149
• Report Number: 1220246-2022-04430
• Device Sequence Number: 19260908
• Product Code: LXH
• UDI-Device Identifier: 00888867233768
• UDI-Public: 00888867233768
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/03/2022

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 Model Number: PASSER, CERCLAGE WIRE, BENT
• Device Catalogue Number: AR-5050-10
• Device Lot Number: 47321811
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown