MAUDE Adverse Event Report: ARTHREX, INC. 45 DEG CURVE LEFT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	45 DEG CURVE LEFT, QUICKPASS LASSO
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a arthroscopic stabilization surgery the surgeon was using a 45 curve left quickpass lasso in a stabilization case.He reports that he put a lot of force through the item which then snapped off at the tip.The broken piece was easily retrieved and there was no injury to the patient.The team opened another of the same item and completed the case without any further issues.The team disposed of the broken item.The consultant and the team were not concerned, he said he was definitely putting too much force through the item.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.
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.

• Brand Name: 45 DEG CURVE LEFT, QUICKPASS LASSO
• 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: 15310897
• Report Number: 1220246-2022-05427
• Device Sequence Number: 5467017
• Product Code: LXH
• UDI-Device Identifier: 00888867038929
• UDI-Public: 00888867038929
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

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: 45 DEG CURVE LEFT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-45L
• Device Lot Number: 1327117445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/29/2022
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown