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

Model Number	SUTURESNARE, 90 STRAIGHT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
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.
Event or Problem 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.
Additional 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
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11540272
• Report Number: 1220246-2021-02756
• Device Sequence Number: 4108405
• Product Code: LXH
• UDI-Device Identifier: 00888867204638
• UDI-Public: 00888867204638
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 05/20/2021
• Patient Sequence Number: 1