MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS LARGE TGTR 3.7MM R DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71177735
Medical Device Problem Codes	Material Fragmentation (1261); Separation Failure (2547); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number:(b)(4).
Event or Problem Description
It was reported that, during evos large pp internal fixation surgery, one (1) evos large tgtr 3.7mm r drill got jammed in the drill sleeve, after penetrating the near cortex.The procedure was resumed, after a non-significant delay, using a s+n back-up device.After the procedure, the parts were separated exhibiting small amounts of metal debris presumably coming from the drill flutes.No further complications were reported.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned evos large tgtr 3.7mm r drill reveals a few burrs on the body of the device and at the tip of the device.The visual did not reveal any metal pieces missing from the device.Also the evos 3.7mm locking guide was returned and the visual reveals signs of normal wear and use.This inspection was conducted using a magnifying glass.A functional evaluation reveals the evos large tgtr 3.7mm r drill go through the evos 3.7mm locking guide as intended.There is no issue inserting the evos large tgtr 3.7mm r drill and removing it from the evos 3.7mm locking guide.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the drill, 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.For the locking guide, a review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.The drill is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.The locking guide 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.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 for future complaints and investigate as necessary.We consider this investigation closed.
Event or Problem Description
It was reported that, during evos large pp internal fixation surgery, one (1) evos large tgtr 3.7mm r drill got jammed in one (1) evos large 3.7mm locking {} guide, after penetrating the near cortex.The procedure was resumed, after a non-significant delay, using a s+n back-up device.After the procedure, the parts were separated exhibiting small amounts of metal debris presumably coming from the drill flutes.There was no need to conduct an examination for potential fallen metal debris.No further complications were reported.

• Brand Name: EVOS LARGE TGTR 3.7MM R DRILL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 19520912
• Report Number: 1020279-2024-01139
• Device Sequence Number: 6171624
• Product Code: LXH
• UDI-Device Identifier: 00885556767733
• UDI-Public: 885556767733
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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
• Device Catalogue Number: 71177735
• Device Lot Number: 22CUQ0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71175629/EVOS LARGE 3.7MM LOCKING {} GUIDE
• Patient Sex: Unknown