MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAN/FAN PERC DRILL GUIDE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71631021

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2020

Event Type  Injury  

Event Description

It was reported that during trauma surgery intertan tan hip fracture repair. Targeting is off with guide and drop, therefore screws aren't aligning with nail. There was a delay was under 30 minute however the added time keeps the patient under anesthesia longer than necessary. The procedure was completed using the original device and the surgeon changing their technique- to a freehand approach to target screws. No injury reported.

Manufacturer Narrative

The device, intended use in treatment, was not returned for evaluation, the reported event could not be confirmed. The clinical/medical team concluded, per subsequent email, the requested relevant clinical information is unavailable. Therefore, a thorough investigation cannot be rendered. Based on the limited information provided, the surgeon¿s change in surgical technique - to a freehand approach to target the screws, and the reported delay of under 30 minutes, did not result in patient injury/impact; therefore, no further medical assessment is warranted at this time. Should additional medical information be provided, this complaint will be re-assessed. At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture. A complaint history review found related failures; 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. Damage from prolonged use, misuse or rough handling are likely probable causes of 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. This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur. Without the actual product involved, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. We consider this investigation closed.

• Brand Name: TAN/FAN PERC DRILL GUIDE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10177298
• Report Number: 1020279-2020-02630
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010604873
• UDI-Public: 03596010604873
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 71631021
• Device Catalogue Number: 71631021
• Device Lot Number: 07HM21994A
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Hospitalization; Required Intervention