MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	7210423
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the two guides of the accu-pass had a problem.Specifically, when passing the suture and turning the wheels, the guide came off.When the user reviewed the guides, they showed deterioration and breakage.The procedure was successfully completed without surgical delay using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported events could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failures and/or harms were documented appropriately, and there were no indications to suggest the anticipated risks are not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with these events is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The suture shuttle was returned with 2 monofilaments that are badly damaged, wadded up and bent.A functional assessment of the device found that the suture shuttle appropriately advances and retracts a reference monofilament, the returned monofilament is too damaged to be used successfully with the returned device or a reference suture shuttle.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failures and/or harms were documented appropriately, and there were no indications to suggest the anticipated risks are not adequate.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device.No containment or corrective actions are recommended at this time.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18607740
• Report Number: 1219602-2024-00171
• Device Sequence Number: 2820911
• Product Code: LXH
• UDI-Device Identifier: 03596010534446
• UDI-Public: 03596010534446
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2024

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 Expiration Date: 11/08/2025
• Device Catalogue Number: 7210423
• Device Lot Number: 2103521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/27/2024; 05/02/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/28/2024; 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male