MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG SCREW DRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71631440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a removal procedure of a meta-tan nail, the inner rod of the meta-tan lag screw driver which was connected to the lag screw broke off.The piece remains at the connection part of the lag screw.The procedure was cancelled and the nail could not be removed.No furhter complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a removal procedure of a meta-tan nail, the inner rod of a meta-tan lag screw driver broke.The broken piece of the meta-tan lag screw could not be removed from the nail, therefore the nail could not be removed.The procedure was cancelled, and there is no surgery planned at the moment.No further complications were reported.
Additional Manufacturer Narrative
H2: additional information ¿b5, d4, h6¿.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed that a piece of the threaded end broke off and a piece of the retaining rod cap is broken off.These pieces were not returned.The retaining rod and the lag screw driver both were returned.The device exhibits signs of significant wear and use.This inspection was conducted using a magnifying glass.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 instructions for use 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.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 evidence to conclude that the product failed to meet any 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.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.

• Brand Name: META-TAN LAG SCREW DRIVER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 19740971
• Report Number: 1020279-2024-01369
• Device Sequence Number: 7673932
• Product Code: HSB
• UDI-Device Identifier: 00885556158340
• UDI-Public: 00885556158340
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2024

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 Catalogue Number: 71631440
• Device Lot Number: 16ESY0086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 08/07/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/23/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown