MAUDE Adverse Event Report: ARTHREX, INC. POINTED REDUCTION FORCEPS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	POINTED REDUCTION FORCEPS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2022
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 (b)(6) 2022 it was reported by a sales representative via sems that the tip of the ar-18700-45 bone forceps broke off while trying to reduce a lisfranc fx, haven¿t been able to find the top of the forceps but it¿s not in the patient.This was discovered during use in procedure on (b)(6) 2022.Additional information 1/25/2022 on (b)(6) 2022 it was reported by a sales representative via sems that the pointed reduction clamp tip broke off of the ar-18700-45 bone forceps while trying to reduce a lisfranc fx.The clamp was inside of the patient when it broke and fragment was not found.This was discovered during use in a tmt fusion on (b)(6) 2022.The surgeon used an x-ray however, still unable to locate the broken fragment.The case was completed by using a lobster claw.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that one of the tips of the forces had broken off.No damaged observed to the other tip.Device functioning showed device works as intended.The cause of this event is undetermined; however, the observed condition is most likely the result of user applied mechanical damage during use, such as through prying/leveraging and/or torquing the forceps.

• Brand Name: POINTED REDUCTION FORCEPS
• 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: 13472351
• Report Number: 1220246-2022-04436
• Device Sequence Number: 1714192
• Product Code: LXH
• UDI-Device Identifier: 00888867317949
• UDI-Public: 00888867317949
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/01/2022

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: POINTED REDUCTION FORCEPS
• Device Catalogue Number: AR-18700-45
• Device Lot Number: 6671931
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown