MAUDE Adverse Event Report: ARTHREX, INC. LOBSTER CLAW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	LOBSTER CLAW
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
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
It was reported that the ar-8943-23 broke during use.A second lobster claw was brought in and used to complete the procedure.The rep reported there was no patient harm.
Additional Manufacturer Narrative
The complaint is confirmed.The device was not received for investigation, however pictures were provided of the alleged device.Review of the pictures show that the distal tip of the lobster claw had broken off from the rest of the device.Additionally it can be seen that the laser marking on the device has faded and is discolored.As the device was not returned for investigation the cause of the breakage could not be determined, however the cause typically attributed to this type of failure is excessive force being applied to the device.

• Brand Name: LOBSTER CLAW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11990337
• Report Number: 1220246-2021-03248
• Device Sequence Number: 4166735
• Product Code: LXH
• UDI-Device Identifier: 00888867052321
• UDI-Public: 00888867052321
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 10/22/2021

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: LOBSTER CLAW
• Device Catalogue Number: AR-8943-23
• Device Lot Number: 12291411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 10/22/2021
• Patient Sequence Number: 1