MAUDE Adverse Event Report: ARTHREX, INC. SUTURESNARE, 90 STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number SUTURESNARE, 90 STRAIGHT

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

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.

Event Description

It was reported that the device didn`t deploy without using great force during a rotator cuff repair surgery.There was no harm or adverse event for patient, operator or third party reported.No piece of the device broke off during the procedure.The surgeon switched to a different surgical technique using a 45 deg l lasso.The surgery was finished successfully with a different device (ar-6068-45l).It was not necessary to do a second surgery.Update 05-mar-2021: it was further reported that the surgery took 30 minutes longer because sutures had to be shuttled.No extra incisions were required to be made.Update 08-mar-2021: the duration of the operation was in the region of 1hr 30 - 1hr 40min.

Manufacturer Narrative

Complaint confirmed.Two unpackaged ar-6060-90 suturesnare suture passers (no batch identifiers present) were received for investigation.Functional testing identified that the wires of each suturesnare could be both retracted and deployed when actuated.However, resistance was noted during the operation of both devices.The root cause of the observed condition remains undetermined.A potential most probable cause can be attributed to misalignment of the gears within the handle assemblies, although this cannot be determined without disassembly.

• Brand Name: SUTURESNARE, 90 STRAIGHT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11540272
• MDR Text Key: 242919407
• Report Number: 1220246-2021-02756
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867204638
• UDI-Public: 00888867204638
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: SUTURESNARE, 90 STRAIGHT
• Device Catalogue Number: AR-6060-90
• Device Lot Number: 10192453
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2021
• Patient Sequence Number: 1