MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENDON STRIPPER SLOTTED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	013554
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an acl ligamentoplasty, the tendon stripper slotted end broke when the tendon was removed, and it was left in the patient because it could not be found.The procedure was completed using the same reported device it is unknown if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, images evaluation was performed and found the tip is broken.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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 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 failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned with any original packaging.Lot number mpg008746 is laser etched on the device.The distal tip of the device has fractured away and was not returned.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.Based on the information available, 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 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.A clinical review states a photo of the device was provided for review and confirms the reported breakage; however, it does not indicate a root cause for the breakage.The tendon stripper slotted is an externally communicating device, it is neither manufactured nor intended for implantation.Long-term implantation data is not available.The patient impact is determined to be the retained tendon stripper slotted end with potential risk for tissue inflammation and/or pain.Micro-motion or movement cannot be predicted.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (application of unintended inappropriate or excessive force to the device, or an impact event inconsistent with normal use).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TENDON STRIPPER SLOTTED
• 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: 19878714
• Report Number: 1219602-2024-01644
• Device Sequence Number: 7086190
• Product Code: LXH
• UDI-Device Identifier: 03596010091093
• UDI-Public: 03596010091093
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/28/2025

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: 013554
• Device Lot Number: UNKNOWN
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 08/27/2025
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 09/12/2024; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Sex: Unknown
• Patient Weight: 62 KG