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

Model Number PUNCH,DISP CRKSCRW SWVLK ANCHS

Device Problems Loose or Intermittent Connection (1371); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2021

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 283765225
• Report Number: 1220246-2021-04087
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867023567
• UDI-Public: 00888867023567
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: PUNCH,DISP CRKSCRW SWVLK ANCHS
• Device Catalogue Number: AR-1927PBS
• Device Lot Number: 12982434
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1