MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO SD WIRE LOOP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number SUTURELASSO SD WIRE LOOP

Device Problems Disconnection (1171); Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2022

Event Type  malfunction  

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 Description

The surgeon was using the swift stitch to pass a suture through the labrum of the hip.He made one pass and when he brought the instrument out of the trim it cannula, the teeth would not advance as the sheath had disconnected from the shaft of the swift stitch.

Manufacturer Narrative

The complaint is confirmed based on the customer-provided photo, which displays the ar-4068-05sd wire loop caught within the broken suturelasso.However, as the devices involved in the event were not returned for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: SUTURELASSO SD WIRE LOOP
• Type of Device: 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: 13471392
• MDR Text Key: 287899482
• Report Number: 1220246-2022-04405
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867031418
• UDI-Public: 00888867031418
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUTURELASSO SD WIRE LOOP
• Device Catalogue Number: AR-4068-05SD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1