MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS NEEDLE,SINGLE PACK,STERILE BX 5; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72203793
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a shoulder tendon repair surgery, the truepass needle had a break.It broke in the patient, and could not be found, but was left secured.Surgery was completed with the same device.There was a delay of less than 30 minutes, and no further complications were reported.Patient's status is fine.
Additional Manufacturer Narrative
H11: h2: corrected information in b1 and b2.
Additional Manufacturer Narrative
H11: internal complaint reference: case-(b)(4).H2: updated information in h6 (health effect - clinical code) h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, a clinical review states that a photo of the device was provided for review however it does not aid in determining the root cause for the breakage.We are currently unable to rule out a user technique vs procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The truepass needle is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact is determined to be the retained non implantable needle fragment.There is potential risk for tissue inflammation and/or pain.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 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 instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.The root cause could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include excessive force to the device.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: h2: corrected data in h6 (health effect - clinical code).
Additional Manufacturer Narrative
H2: corrected information in h6 (component code).H3, h6: the reported device was received for evaluation.A visual evaluation showed that the needle tip has fragmented from the device and was not returned.The distal end of the needle is bent.There is a shiny abrasion spot, not blue/purple, on either side of the distal end of the needle.A clinical review states that a photo of the device was provided for review however it does not aid in determining the root cause for the breakage.We are currently unable to rule out a user technique vs procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The truepass needle is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact is determined to be the retained non implantable needle fragment.There is potential risk for tissue inflammation and/or pain.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 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 instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.The root cause could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include excessive force to the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TRUEPASS NEEDLE,SINGLE PACK,STERILE BX 5
• 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: 22465538
• Report Number: 1219602-2025-01707
• Device Sequence Number: 17211588
• Product Code: NBH
• UDI-Device Identifier: 00885554030433
• UDI-Public: 885554030433
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72203793
• Device Lot Number: 2147851
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 08/08/2025; 08/08/2025; 10/01/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/10/2025; 08/11/2025; 08/18/2025; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown