MAUDE Adverse Event Report: ARTHREX, INC. PUNCH,DISP CRKSCRW SWVLK ANCHS; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	PUNCH,DISP CRKSCRW SWVLK ANCHS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair surgery the device was inserted and could not be removed because the blue handle loosened.The blue handle has rotated accordingly and could only be removed with a pair of pliers and a hammer.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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.
Additional Manufacturer Narrative
Complaint not confirmed, the shaft was not found to be loose.The distance of the shaft protruding from the handle was also found to meet specifications, indicating the shaft did not move relative to the handle.The shaft was found to be scratched near the handle and the distal end of the handle is deformed.The damage was likely caused by the tooling described in the complaint description.

• Brand Name: PUNCH,DISP CRKSCRW SWVLK ANCHS
• 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: 12983632
• Report Number: 1220246-2021-04087
• Device Sequence Number: 11907819
• Product Code: MDM
• UDI-Device Identifier: 00888867023567
• UDI-Public: 00888867023567
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 02/11/2022

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 Expiration Date: 02/28/2026
• Device Model Number: PUNCH,DISP CRKSCRW SWVLK ANCHS
• Device Catalogue Number: AR-1927PBS
• Device Lot Number: 12982434
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown