MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 25 DEGREE TIGHT CURVE RIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTURELASSO, 25 DEGREE TIGHT CURVE RIGHT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by an arthrex employee via e-mail that an ar-4068-25tr suturelasso broke.This occurred on (b)(6) 2021 during a shoulder procedure when the surgeon manipulated the suturelasso into the patient and it broke.The fragments were retrieved, and the case was completed.There was no patient effect reported.Additional information provided on 12/21/2021 : the procedure being performed was an instability.The suture broke, and the fragment was able to be retrieved.The case was completed using the bird's beak forceps.
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.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the tip of the device had broken off of the shaft.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: SUTURELASSO, 25 DEGREE TIGHT CURVE RIGHT
• 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: 13189879
• Report Number: 1220246-2022-04250
• Device Sequence Number: 14801747
• Product Code: LXH
• UDI-Device Identifier: 00888867031449
• UDI-Public: 00888867031449
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 01/13/2022

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 Expiration Date: 08/31/2024
• Device Model Number: SUTURELASSO, 25 DEGREE TIGHT CURVE RIGHT
• Device Catalogue Number: AR-4068-25TR
• Device Lot Number: 925997228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 01/13/2022
• Date Device Manufactured: 10/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown