MAUDE Adverse Event Report: ARTHREX, INC. PUNCH WDBITE STR TIP,2.75MM S. SFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	PUNCH WDBITE STR TIP,2.75MM S. SFT
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
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 04/02/2024, it was reported by a distributor via (b)(4) that an ar-11040 punch clamp does not close.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-11040 widebiter punch lot number: 10244850 was received for investigation.Visual evaluation of the device noted that the tip pin was missing and the punch was not opening and closing as intended.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse due to use error.Refer to investigation photos.

• Brand Name: PUNCH WDBITE STR TIP,2.75MM S. SFT
• 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: 19183364
• Report Number: 1220246-2024-02406
• Device Sequence Number: 7431128
• Product Code: MDM
• UDI-Device Identifier: 00888867002692
• UDI-Public: 00888867002692
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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): 08/28/2024

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 WDBITE STR TIP,2.75MM S. SFT
• Device Catalogue Number: AR-11040
• Device Lot Number: 10244850
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• 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