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

Model Number	PUNCH WDBITE STR TIP,2.75MM S. SFT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
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 06/22/2022 it was reported by a distributor via sems that an ar-11040 punch, is broken.This was discovered during an unspecified procedure, with no patient harm reported.Requested additional information.
Additional Manufacturer Narrative
Complaint not confirmed.Upon visual inspection, it was noted that the device was bent, no piece was broken off.Upon functional testing, it was noted that the device was dull.
Additional Manufacturer Narrative
Complaint not confirmed.Upon visual inspection, it was noted that the device was bent, no piece was broken off.Upon functional testing, it was noted that the device was dull.

• Brand Name: PUNCH WDBITE STR TIP,2.75MM S. SFT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14976712
• Report Number: 1220246-2022-05208
• Device Sequence Number: 14695781
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2022

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: 72506
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 06/22/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/31/2022; 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown