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

Model Number	LOBSTER CLAW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
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 on (b)(6) 2023 by a distributor via sems that an ar-8943-23 lobster claw broke in half during the bony reduction.All fragments retrieved.Case involvement, device broke during use.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual evaluation, one of the jaws is broken.The most probable cause is by applying excessive force while grasping and manipulating tissue or when applying excessive leveraging forces.However, the broken piece was not returned for investigation.The laser marks are faded.The cause remains undetermined.Functional testing was not performed due to the damage 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16845065
• Report Number: 1220246-2023-06647
• Device Sequence Number: 6860692
• Product Code: LXH
• UDI-Device Identifier: 00888867052321
• UDI-Public: 00888867052321
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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: 12291414
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 08/16/2023
• 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