MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 125 RAD DRILL GDE DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71674002
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, on (b)(6) 2024, during internal fixation surgery, dr.(b)(6) was implanting a short intertan nail into one of his patients that presented with an intertrochanteric fracture.When it came to drilling for the distal interlock screw, through one (1) 125 rad drill gde drop, the drill missed the screw hole through the nail.At first, it was thought that it hit the nail's edge, and then it drilled through the screw hole.However, after taking a lateral x-rays, it could be seen that the screw was posterior outside of the nail.The screw was removed, a second intertan set was opened, and it was used another 125 rad drill gde drop, but the same exact event happened.This time, it ended up fracturing the patient's femur, at the level of the distal interlock screw.The placement of the distal interlock screw was aborted, and it was placed a competitors synthes proximal femur plate on the patient's femur.The next day, they went through the system and checked everything.It was discovered that both125 rad drill gde drops were loose enough to allow a drill to potentially miss the short nail.Both drops used on same handle.The procedure was completed after a significant delay greater than 30 minutes, with a competitor's device.Patient is stable and doing well.

• Brand Name: 125 RAD DRILL GDE DROP
• 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: 20333936
• Report Number: 1020279-2024-01972
• Device Sequence Number: 21239751
• Product Code: HSB
• UDI-Device Identifier: 03596010570970
• UDI-Public: 3596010570970
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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: 71674002
• Device Lot Number: 16EM20573
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown