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

Model Number	LOBSTER CLAMP, RADIOLUCENT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
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
On (b)(4) 2022, it was reported by a sales representative via sems that an ar-18700-49 lobster clamp, radiolucent had an issue.Using the mini cfs set for a 5th met procedure on (b)(6) 2022, the surgeon asked for the ar-18700-49 lobster clamp and started applying pressure to clamp the bone, and one side of the clamp broke off.The piece was retrieved from the patient.The rep observed the surgeon performing the procedure and he said that he was not applying excessive force to the clamp.An alternate clamp from the set was used and the procedure was completed successfully.The piece that broke off was discarded by the hospital, the other piece was available for return.It looked like the item fell apart and did not break due to neglect.This was discovered during use with no impact to the patient.

• Brand Name: LOBSTER CLAMP, RADIOLUCENT
• 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: 14976691
• Report Number: 1220246-2022-05206
• Device Sequence Number: 5098879
• Product Code: LXH
• UDI-Device Identifier: 00888867317987
• UDI-Public: 00888867317987
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 07/11/2022

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 Model Number: LOBSTER CLAMP, RADIOLUCENT
• Device Catalogue Number: AR-18700-49
• Device Lot Number: 34802042
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/11/2022
• Date Device Manufactured: 12/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown