MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG SCREW TAP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71674009
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an internal fixation surgery, x-rays showed that a tooth from the lag screw tap fractured and was in the patient.The broken tooth was retrieved from patient during the same surgery, using a pair of kocher and hemostat.The procedure was resumed after a non-significant delay using the same device.No further consequences were reported.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Additional Manufacturer Narrative
Additional information: g2, d9.H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the teeth on the tip of the device are broken off.The pieces were not returned.The device shows signs of extensive wear and use.The clinical/medical investigation concluded that definitive contributing clinical factors cannot be concluded based on the limited information provided.Since the foreign body was reportedly successfully removed during a non-significant delay without patient injury, no further patient impact would be anticipated due to the event.A device history records review was not performed for this event since based on the device evaluation; no manufacturing, packaging or labelling defects were associated with the reported failure.A review of complaint history revealed a similar event 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.E1: initial reporter name and address.

• Brand Name: LAG SCREW TAP
• 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: 18461340
• Report Number: 1020279-2024-00032
• Device Sequence Number: 16915984
• Product Code: HSB
• UDI-Device Identifier: 03596010560490
• UDI-Public: 03596010560490
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2024

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
• Device Catalogue Number: 71674009
• Device Lot Number: 06DHU0020
• 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: 12/15/2023
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 01/07/2024
• Supplement Report FDA Received Date: 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown