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

Model Number	74016421
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the surgeon had difficulties to use the femoral peg drill to drill posterior holes through the juk ap femoral blocks.Metal shavings were observed by the surgeon & lavage suctioned from the surgical site.Surgeon had to redrill the posterior hole.No further issues are reported and the delay was a minute or two to redrill the hole.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, metal shavings were observed and removed from the surgical site.Reportedly, the surgeon had difficulty using the femoral lug drill to drill posterior holes through the juk ap femoral blocks, and had to redrill the posterior hole.Per email communication, the x-rays and surgical report are not available.Aside from the need for an additional drill hole, there was no further issues reported, and the procedure was completed with minimal delay.No further medical assessment is warranted at this time.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is 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: 10775375
• Report Number: 1020279-2020-06045
• Device Sequence Number: 13734484
• Product Code: HTW
• UDI-Device Identifier: 00885556692233
• UDI-Public: 00885556692233
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74016421
• Device Catalogue Number: 74016421
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 08/16/2021
• 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: Required Intervention