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

Model Number 74016403

Device Problems Material Fragmentation (1261); Difficult to Insert (1316); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  Injury  

Event Description

It was reported that, during a total knee arthroplasty surgery, while using a femoral peg drill along with a jrny ii uni resect ap block lm/rl sz 3, a large amount of metal lints were generated.The metal lints were retrieved.The procedure was completed, with a non-significant delay, by conducting the peg drilling by freehand.Patient was not harmed beyond the reported problem.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a total knee arthroplasty surgery, while using a femoral peg drill along with a jrny ii uni resect ap block lm/rl sz 3, a large amount of metal lints were generated from the femoral peg drill.The metal lints were retrieved.The procedure was completed, with a non-significant delay, by conducting the peg drilling by freehand.Patient was not harmed beyond the reported problem.

Manufacturer Narrative

Additional information: b5, d10, h4 d1, d2, h6.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.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 potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could not be corroborated.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.

Manufacturer Narrative

The associated devices were returned and evaluated.Visual inspection of the femoral peg drill reveals metal shavings came off the device and the end of the device is rounded off.Visual inspection of the resection cutting block reveals a small scratch on the device.The visual did not reveal any burrs, gouges or metal shavings missing from the device.The devices show signs of normal wear and use.For the femoral peg drill, a review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batches based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the resection cutting block, a review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to these devices and failure mode.A review of instructions for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FEMORAL PEG DRILL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15591246
• MDR Text Key: 301626766
• Report Number: 1020279-2022-04396
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00885556692233
• UDI-Public: 00885556692233
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74016403
• Device Catalogue Number: 74016421
• Device Lot Number: 21CM05878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 74016403/JRNY II UNI RESECT AP BLOCK LM/RL SZ 3.
• Patient Outcome(s): Required Intervention