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

Catalog Number	72203791
Medical Device Problem Codes	Failure to Capture (1081); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alter the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a rotator cuff procedure, the puncture needle of the truepass suture passer could not be installed, as it appeared that the spring at the distal end had come out.The procedure was resumed, after a non-significant delay, with a change in surgical technique to manual suturing.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H2: additional information: h6: medical device problem code.H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was not returned with any original packaging.The etching is faded but legible and the lot matches the complaint.The ends of the torsion spring are bent beyond the outer profile of the upper jaw.A functional evaluation was performed on the returned device and found the bent torsion spring allows it to float around and not hold the trapdoor in place.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 failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that can contribute to the reported event include excessive force or an impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TRUEPASS SUTURE PASSER SELF-CAPTURED
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24318570
• Report Number: 1219602-2026-00453
• Device Sequence Number: 5675866
• Product Code: NBH
• UDI-Device Identifier: 00885554030419
• UDI-Public: 885554030419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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 Catalogue Number: 72203791
• Device Lot Number: 74909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2024
• 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