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	01/24/2023
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
On (b)(6) 2023 it was reported by a sales representative via sems that an ar-6060-90 suture snare broke during a case.The surgeon was attempting to fix a partial subscapularis repair.He penetrated the sub-scap with the suture-snare and used the deploying "snare" to capture a free end of a ar-7237-7 fiber-tape.He moved the thumb position to the "back position" to grasp the suture.As he began to remove the suture-snare device with the fiber-tape end secured in the "snare", the "snare" broke off in the glenohumeral joint.The device was removed and discarded.The broken piece was removed from the joint with an arthroscopic grasper.The case was completed successfully.No patient affect.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when engaging the suture snare actuator assembly.

• Brand Name: SUTURESNARE, 90 STRAIGHT
• Common Device Name: 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: 16361774
• Report Number: 1220246-2023-06273
• Device Sequence Number: 7391383
• Product Code: LXH
• UDI-Device Identifier: 00888867204638
• UDI-Public: 00888867204638
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 08/29/2024

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: SUTURESNARE, 90 STRAIGHT
• Device Catalogue Number: AR-6060-90
• Device Lot Number: 15013247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown