MAUDE Adverse Event Report: ARTHREX, INC. REELPASS SUTR LASSO,45° CRV LFT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REELPASS SUTR LASSO,45° CRV LFT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The reelpass suture jammed during procedure.Also pds suture snapped multiple times.Before the procedure.The device was 'primed' by pulling out 1 metre of suture and ensuring it was working smoothly.The surgeon took apart the reelpass and untangled the spool of pds suture.The procedure was completed successfully.No harm to patient.
Additional Manufacturer Narrative
The complaint is confirmed upon review of the customer-provided photo, which displays the tangled wire along the spool.However, as the device was not returned for physical evaluation, the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.No change in harm was identified.

• Brand Name: REELPASS SUTR LASSO,45° CRV LFT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 19374362
• Report Number: 1220246-2024-03674
• Device Sequence Number: 7724752
• Product Code: LXH
• UDI-Device Identifier: 00888867115866
• UDI-Public: 00888867115866
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 05/22/2024

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: REELPASS SUTR LASSO,45° CRV LFT
• Device Catalogue Number: AR-6069-45L
• Device Lot Number: 10328500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown