MAUDE Adverse Event Report: ARTHREX, INC. BONE REDUCTION FORCEPS W/TEETH; MANUAL INSTR, GENERAL SURGICAL

Model Number	BONE REDUCTION FORCEPS W/TEETH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 21 may 2024 it was reported by a sales rep via email that an ar-4160ft bone reduction forceps w/teeth broke during use.This occurred on (b)(6) 2024 during a mid foot fusion in southern cross hospital wellington.The case was completed successfully with the use of another forceps.There was case involvement.
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 allegation was confirmed.One unpackaged ar-4160ft bone reduction forceps with teeth batch number 672206 was received for investigation.A visual inspection revealed that one of the instrument¿s jaws was broken off.¿ functional testing was performed, attempting to open and close the jaws; however, it was found that they were too tight to move.

• Brand Name: BONE REDUCTION FORCEPS W/TEETH
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19556551
• Report Number: 1220246-2024-05903
• Device Sequence Number: 6716083
• Product Code: MDM
• UDI-Device Identifier: 00888867032996
• UDI-Public: 00888867032996
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• 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): 02/14/2025

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: BONE REDUCTION FORCEPS W/TEETH
• Device Catalogue Number: AR-4160FT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown