MAUDE Adverse Event Report: ARTHREX, INC. PUNCH,MED 3.4 MM15°UP CRVD,220MM W/WB; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	PUNCH,MED 3.4 MM15°UP CRVD,220MM W/WB
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that an ar-15310w punch, broken during a case, patient was not affected.Additional information 02/09/2022: on (b)(6) 2022 it was reported by a sales representative via sems that when the surgeon was using the ar-15310w punch on the labrum, it broke.The instrument broke in the patient but it looks to be an internal breakage of the wish bone area of the handle.Nothing was left in the patient.This was discovered during use in a large calcified hip labrum tear on (b)(6) 2022.The case was completed by using the shaver and banana blade to finish the resection.
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.

• Brand Name: PUNCH,MED 3.4 MM15°UP CRVD,220MM W/WB
• 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: 13569731
• Report Number: 1220246-2022-04497
• Device Sequence Number: 6136890
• Product Code: MDM
• UDI-Device Identifier: 00888867018686
• UDI-Public: 00888867018686
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Report Date (Section B): 02/21/2022

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,MED 3.4 MM15°UP CRVD,220MM W/WB
• Device Catalogue Number: AR-15310W
• Device Lot Number: 83946
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/21/2022
• Date Device Manufactured: 11/03/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown