MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNIFE RASP; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72201661
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder procedure, the knife rasp broke during the scraping and detachment of the tendon, normal force bent and broke it.The broken tip was completely removed from the patient.The procedure was completed using the same faulty device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.A clinical review states that the undated, unlabeled pictures in the complaint confirm the breakage, however, the do not aid in determining the root cause.The impact to the patient was the procedure and the remove of the broken tip.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 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 on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).The reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned device finds the device returned with the distal knife fractured away and biological debris on the shaft and blade.A clinical review states that the undated, unlabeled pictures in the complaint confirm the breakage, however, the do not aid in determining the root cause.The impact to the patient was the procedure and the remove of the broken tip.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 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 on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: KNIFE RASP
• 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: 19454241
• Report Number: 1219602-2024-01225
• Device Sequence Number: 7025181
• Product Code: NBH
• UDI-Device Identifier: 03596010606297
• UDI-Public: 03596010606297
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2024

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 Catalogue Number: 72201661
• Device Lot Number: 50520915
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 08/26/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/12/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• 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 Age: 24 YR
• Patient Sex: Male