MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL PEG DRILL; BIT, DRILL

Model Number	74016421
Medical Device Problem Codes	Material Fragmentation (1261); Connection Problem (2900)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka surgery the femoral peg drill was not fitting properly inside the posterior lug hole of the juk ap femoral cutting block.The drill was scratching against the block and leaving metal debris in the patient.The procedure was completed with a less than or equal to 30 mins delay using the same device.No other complications were reported.
Additional Manufacturer Narrative
The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.The clinical/medical team concluded, without responses to the documentation/information requests, the reported event could not be further assessed and the root cause of the reported scratching with subsequent metal debris could not be definitively concluded.The externally communicating device is neither manufactured nor intended for implantation; and is not approved for long term internal tissue exposure and long term implantation data is not available.The patient impact beyond the reported device shedding metal debris with unknown foreign body status could not be determined.Although unlikely, the potential for corrosion and local irritation/migration of any potential retained fragments could not be ruled out.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated at this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FEMORAL PEG DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11449968
• Report Number: 1020279-2021-01945
• Device Sequence Number: 3513546
• Product Code: HTW
• UDI-Device Identifier: 00885556692233
• UDI-Public: 00885556692233
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74016421
• Device Catalogue Number: 74016421
• Device Lot Number: 18CM18149
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention