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

Catalog Number	7207179
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Codes	Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unspecified arthroscopy, the tendon stripper couldn't cut the graft at the moment of removal and another incision was necessary to complete the procedure.The procedure was completed using the same device.There was a 30 minutes surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference case-(b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event 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 similar reported events.The instructions for use were 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 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.A clinical review states that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported additional incision and 30 minutes surgical delay cannot be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.H11: corrected information in h6 (health effect - clinical & impact codes).
Additional Manufacturer Narrative
H2: additional information in d4 and h4 (exp.And mfg.Dates).
Additional Manufacturer Narrative
H11: corrected information in d4 (lot no.) & h4 (mfg.Date).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).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 device shows definite wear from use, the laser etchings are legible.A functional evaluation of the device found that it was unable to cut cleanly through the testing material.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.The instructions for use were 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 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.A clinical review states that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported additional incision and 30 minutes surgical delay cannot be determined.The root cause has been associated with component failure.Factors that can contribute to the reported event include wear from use or excessive force of the device.No containment or corrective actions are recommended at this time.

• Brand Name: STRIPPER TENDON LARGE
• 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: 17733412
• Report Number: 1219602-2023-01748
• Device Sequence Number: 17722020
• Product Code: LXH
• UDI-Device Identifier: 03596010253460
• UDI-Public: 03596010253460
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/14/2024

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: 7207179
• Device Lot Number: 50849747
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/31/2023; 10/31/2023; 01/24/2024; 03/12/2024
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 11/01/2023; 11/01/2023; 01/25/2024; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male