MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREWDRIVER RELEASE HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71674084
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an internal fixation surgery for a hip fracture, the intertan nail cap 0.0mm was stripped (case (b)(4)), it got stuck to a (1) medium hexdriver (case (b)(4)).Additionally, the end of a (1) screwdriver release handle was bent and broke off while trying to get the capture off the medium hex driver (case (b)(4)).After removing the nail cap, it broke off on the back table.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery for a hip fracture, the end of a (1) screwdriver release handle was bent and broke off while trying to get the capture off the medium hex driver.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.Patient's status is fine.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the tip of the device is fractured off.The remaining parts of the end of the device is bent and twisted.The device shows signs of wear from use.This inspection was conducted by the naked eye.A review of the production orders 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 part number 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 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: SCREWDRIVER RELEASE HANDLE
• 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: 20976886
• Report Number: 1020279-2024-02697
• Device Sequence Number: 17174178
• Product Code: HSB
• UDI-Device Identifier: 03596010560810
• UDI-Public: 3596010560810
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71674084
• Device Lot Number: 17EM03842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTERTAN NAIL CAP 0.0MM / 71675040; MEDIUM HEXDRIVER / 71631066
• Patient Sex: Unknown