MAUDE Adverse Event Report: ARTHREX, INC. 90 DEG TIGHT CURVE QUICKPASS LASSO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	90 DEG TIGHT CURVE QUICKPASS LASSO
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
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)(6) 2022, it was reported by an arthrex employee via sems that an ar-6068-90t 90 deg.Tight curve quickpass lasso had an issue.The sd wire loop broke when the doctor pulled it out after hooking the first stitch during a procedure on (b)(6) 2022.Used a new product and the case was completed.No patient harm.This was discovered during use with no impact to the patient.Additional information has been requested.On (b)(6) 2022, the arthrex employee stated the following information via email: this event occurred during an arcr procedure.The wire loop broke inside the patient, all fragments were retrieved and removed.This was a quick pass device and was only reloaded once.There was no affect to the patient.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the wire loop had broken and the coating had been removed.The cause of this remains undetermined.

• Brand Name: 90 DEG TIGHT CURVE 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: 13928413
• Report Number: 1220246-2022-04652
• Device Sequence Number: 4843471
• Product Code: LXH
• UDI-Device Identifier: 00888867038974
• UDI-Public: 00888867038974
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 01/31/2026
• Device Model Number: 90 DEG TIGHT CURVE QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90T
• Device Lot Number: 1014109339
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown