MAUDE Adverse Event Report: ARTHREX, INC. MICRO SUTURELASSO, SMALL CURVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MICRO SUTURELASSO, SMALL CURVE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/5/2022, it was reported by an arthrex employee via email that an ar-8701 micro suture lasso looped wire broke while trying to remove it with a grasper.This was discovered during an unspecified procedure on (b)(6) 2022.Case was completed using a product from another manufacturer.
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
The complaint is not confirmed.(1) unpackaged ar-8701 was received for evaluation.The wire loop was not returned.Visual evaluation revealed no apparent issues with the device.Since the wire loop was not returned, the allegation cannot be verified.No problems were found with the returned device.

• Brand Name: MICRO SUTURELASSO, SMALL CURVE
• 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: 15615524
• Report Number: 1220246-2022-05635
• Device Sequence Number: 12771411
• Product Code: LXH
• UDI-Device Identifier: 00888867044722
• UDI-Public: 00888867044722
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/03/2023

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: MICRO SUTURELASSO, SMALL CURVE
• Device Catalogue Number: AR-8701
• Device Lot Number: 2047119525
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown