MAUDE Adverse Event Report: ARTHREX, INC. CRESCENT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	CRESCENT, QUICKPASS LASSO
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
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 03/02/2022, it was reported by a sales representative via sems that an ar-6068c crescent, quickpass lasso had an issue, the tip pulled off in the case, and was removed safely.This was discovered during use with no impact to the patient.On 03/16/2022, the sales representative stated the following case information via email and over the phone for additional clarification: this event occurred during a labrum repair.When the surgeon used the complaint device, the metal tip broke off and was embedded in the labrum.It took a while to find the tip.In order to remove it, they shaved tissue away and used suction to place it in reach of the grasper.Once they accomplished that, they switched to a different quickpass lasso (part and lot number unknown) to complete the procedure successfully.The procedure was delayed by 15 minutes, no additional anesthesia was required and there was no harm to the patient since they were able to remove it.The patient is fine to date.

• Brand Name: CRESCENT, 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: 13839724
• Report Number: 1220246-2022-04627
• Device Sequence Number: 14897706
• Product Code: LXH
• UDI-Device Identifier: 00888867038981
• UDI-Public: 00888867038981
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/21/2022

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 Expiration Date: 09/30/2026
• Device Model Number: CRESCENT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068C
• Device Lot Number: 1259115715
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/21/2022
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown