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

Catalog Number 74016421

Device Problem Flaked (1246)

Patient Problem Injury (2348)

Event Date 12/10/2019

Event Type  Injury  

Event Description

It was reported that during surgery the femoral drill was leaving metal shavings while using the instrument.Shavings fell inside the incision and were not able to be completely removed from the patient.Delay under 30 min.No back up device was available, no injury to patient.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, reportedly while using the device, metal shavings fell inside the incision.It was communicated that not all of the shavings where able to be completely removed from the patient.It was also communicated that the part number could not be corroborated because ¿the drill was damaged so the number was worn away.¿ no delay or patient injuries are being reported.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Based on the limited information provided, the root cause of the reported issue could not be determined.The damage to the drill cannot be rule out as a contributing factor.The material is not an implantable alloy; therefore, long-term implantation data is not available.The impact to the patient is the retained non-implantable fragment, possible local irritation and additional radiological imaging/exposure cannot be completely ruled out.No further medical assessment can be rendered at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.These devices are reusable instruments 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.

• Brand Name: FEMORAL PEG DRILL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9555868
• MDR Text Key: 173845773
• Report Number: 1020279-2020-00116
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74016421
• Device Lot Number: 18KM12113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention