MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS SUTURE PASSER SELF-CAPTURE; ACCESSORIES,ARTHROSCOPIC

Model Number	72203791
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a rotator cuff repair procedure, the truepass suture passer grasping mechanism could not open or close due to a faulty spring mechanism.A part of the jaw also broke off.The procedure was completed with a non-significant delay using a smith and nephew back-up device.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the customer provided image revealed the torsion spring has extended beyond the outer profile of the upper jaw.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with component failure.Factors, which could have contributed to the complaint event, include an application of excessive stress or use of the device.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection revealed it is not in its original packaging.The spring on the suture grabber at the distal end of the shaft is fractured.The device shows wear from use.A functional evaluation found the device would not function properly due to the broken spring.A review of the customer provided image revealed the torsion spring has extended beyond the outer profile of the upper jaw.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with component failure.Factors, which could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: TRUEPASS SUTURE PASSER SELF-CAPTURE
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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: 14741334
• Report Number: 1219602-2022-00892
• Device Sequence Number: 15105280
• Product Code: NBH
• UDI-Device Identifier: 00885554030419
• UDI-Public: 00885554030419
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2024

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: 72203791
• Device Catalogue Number: 72203791
• Device Lot Number: 44362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 07/25/2022; 02/06/2024
• Initial Report FDA Received Date: 06/19/2022
• Supplement Report FDA Received Date: 07/27/2022; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown