MAUDE Adverse Event Report: ARTHREX, INC. BONE REDUCTION FORCEPS W/TEETH

Model Number	BONE REDUCTION FORCEPS W/TEETH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
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 during a left hindfoot fusion surgery the jaw of grasper broke in-case.All broken parts were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-4160ft bone reduction forceps with teeth batch 6671817 was received for evaluation.The visual evaluation revealed that one of the curved jaws was broken off.The more in-depth visual evaluation found that the laser marks are faded.The device's manufacturing date 10-sep-2018.Functional testing was not done as the device was received broken/damaged.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: BONE REDUCTION FORCEPS W/TEETH
• 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: 20269348
• Report Number: 1220246-2024-07788
• Device Sequence Number: 11645525
• Product Code: MDM
• UDI-Device Identifier: 00888867032996
• UDI-Public: (01)00888867032996(11)180910(10)6671817
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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
• Device Lot Number: 6671817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2018
• 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