MAUDE Adverse Event Report: ARTHREX, INC. REELPASS SUTR LASSO,45 CRV LFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	REELPASS SUTR LASSO,45° CRV LFT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2021
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 during a left shoulder arthroscopy with capsulorraphy, once the surgeon introduced the reelpass into the joint of the patient, the device fed some monofilament but then stopped shortly after, not leaving enough monofilament to remove the device from the joint and retrieve the monofilament.The scrub tech tried to prime the device by forcefully pulling suture through, but when reintroduced into the joint the same issue occurred.The case was completed by using a new ar-6069-45l without further issue.

• Brand Name: REELPASS SUTR LASSO,45 CRV LFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12300819
• Report Number: 1220246-2021-03503
• Device Sequence Number: 4181701
• Product Code: LXH
• UDI-Device Identifier: 00888867115866
• UDI-Public: 00888867115866
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/10/2021

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 Expiration Date: 11/30/2025
• Device Model Number: REELPASS SUTR LASSO,45° CRV LFT
• Device Catalogue Number: AR-6069-45L
• Device Lot Number: 12221645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1