MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNIFE RASP; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Model Number	72201661
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a shoulder arthroscopy with a knife rasp, when detaching the tendon, the clamp broke, leaving a part of it inside the patient.The broken piece was removed from the patient with the help of a grasper.The procedure was completed without surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.An analysis of the customer provided image shows the device and the clamp of the knife rasp broke in half.The root cause was associated with unintended use of the device.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.No containment or corrective actions are recommended at this time.

• Brand Name: KNIFE RASP
• Common Device Name: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
• 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: 16491641
• Report Number: 1219602-2023-00327
• Device Sequence Number: 6451986
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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 Model Number: 72201661
• Device Catalogue Number: 72201661
• Device Lot Number: 50497449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 07/28/2023
• Date Device Manufactured: 03/26/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male