MAUDE Adverse Event Report: ARTHREX, INC. PUNCH, WIDEBITER, 3.4 MM STRAIGHT; MANUAL INSTR, GENERAL SURGICAL

Model Number	PUNCH, WIDEBITER, 3.4 MM STRAIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
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 28-dec-2023, it was reported by a sales representative via (b)(4) that a widebiter punch, ar-12040, split into two pieces.Occurred during a case, no adverse effect to the patient.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpacked ar-12040 serial/batch number (b)(6) was received for evaluation.Upon visual inspection, it was determined that the finger had become detached from the instrument, likely due to a missing pin.The most probable cause of the reported failure is misuse by the end user.

• Brand Name: PUNCH, WIDEBITER, 3.4 MM STRAIGHT
• 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: emily shafer ; 8009337001
• MDR Report Key: 18571124
• Report Number: 1220246-2024-00498
• Device Sequence Number: 8203855
• Product Code: NBH
• UDI-Device Identifier: 00888867004016
• UDI-Public: 00888867004016
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/18/2024

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: PUNCH, WIDEBITER, 3.4 MM STRAIGHT
• Device Catalogue Number: AR-12040
• Device Lot Number: 10466358
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• 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