MAUDE Adverse Event Report: ARTHREX, INC. BONE REDUCTION FORCEPS, CURVED, POINTED; MANUAL INSTR, GENERAL SURGICAL

Model Number	BONE REDUCTION FORCEPS, CURVED, POINTED
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/18/2024, it was reported by a sales representative via (b)(4) that (2) ar-8943-07 bone reduction forceps clamps are bent and cannot be used properly.This was discovered during a case with no harm to the patient.
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
The complaint allegation was confirmed.One unpacked ar-8943-07 serial/batch number (b)(6) was received for evaluation.Upon visual inspection, it was observed that the instrument's curved, pointed tip is bent.No functional testing was performed because of the damage to the instrument.The reported failure is most likely due to user error.Improper handling of the instrument can result in damage to the device.

• Brand Name: BONE REDUCTION FORCEPS, CURVED, POINTED
• 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: 18654666
• Report Number: 1220246-2024-00809
• Device Sequence Number: 7056057
• Product Code: MDM
• UDI-Device Identifier: 00888867052178
• UDI-Public: 00888867052178
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/17/2024

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, CURVED, POINTED
• Device Catalogue Number: AR-8943-07
• Device Lot Number: 672236
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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