MAUDE Adverse Event Report: ARTHREX, INC. BONE REDUCTION FORCEPS, CURVED, POINTED

Model Number	BONE REDUCTION FORCEPS, CURVED, POINTED
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that the customer was using the arthrex ankle fracture system a lot and the instruments have gotten broken.There was no harm for patient, operator or third party.This was noticed during after the surgery.There was no case involvement.No further information received.***update dw 09-jan-2025: further information was provided that the devices failed during multiple surgeries.During an ankle fracture surgery the reported ar-8944dh became twisted and the ar-8943-07 was bent.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection identified the tips of the bone reduction forceps, curved, pointed were broken and bent.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user error of the device due to excessive force used to grasp tissue during use.

• Brand Name: BONE REDUCTION FORCEPS, CURVED, POINTED
• Common Device Name: FORCEPS
• 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: 21218042
• Report Number: 1220246-2025-00055
• Device Sequence Number: 8786164
• Product Code: MDM
• UDI-Device Identifier: 00841435116887
• UDI-Public: (01)00841435116887(11)240319(10)672345
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 04/07/2025

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, CURVED, POINTED
• Device Catalogue Number: AR-8943-07
• Device Lot Number: 672345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2024
• 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