MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STRAIGHT CUT RASP; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	71935043
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a latarjet surgery, it was noticed that the straight cut rasp released metal shavings when using it, that remains inside the joint and delays the surgical time, since it was necessary to remove them.The procedure had been completed, after a non-significant delay, using the same device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found what appears to be metal shavings.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 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 to the device or sterilization techniques.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
Updated results of investigation: the reported device was not returned to the designated complaint unit for independent evaluation.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 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.Two intraoperative photos were provided for review and confirm the reported shavings.Based on the limited information provided we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent device malfunction.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.
Event or Problem Description
It was reported that during a latarjet surgery, it was noticed that the straight cut rasp released metal shavings when used.This resulted in a short procedural delay while the surgeon removed the debris.The procedure had been completed, after a non-significant delay, using the same device.No injury was reported as a consequence of this issue.

• Brand Name: STRAIGHT CUT RASP
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 20026905
• Report Number: 1219602-2024-01794
• Device Sequence Number: 7364156
• Product Code: HWE
• UDI-Device Identifier: 00885556645949
• UDI-Public: 885556645949
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2025

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: 71935043
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 02/13/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/27/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown