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	04/09/2021
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 one of the device arms broke off during an ankle fracture case.The broken part did not go into the patient and the case was completed.
Additional Manufacturer Narrative
Complaint confirmed, the distal end of the claw broke off.No other physical damage observed.The cause of the event is undermined, however a likely cause is user-applied mechanical forces.The laser markings were also discolored.The cause of the discoloration is undetermined.

• 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: 11777857
• Report Number: 1220246-2021-03016
• Device Sequence Number: 3792552
• Product Code: LXH
• UDI-Device Identifier: 00888867052321
• UDI-Public: 00888867052321
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/05/2021

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: 12291434
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/05/2021
• Patient Sequence Number: 1