MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAN/FAN RADILUCENT DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631022
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Additional information in health effect - impact code and component code.Results of investigation: 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.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.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.Internal complaint reference: (b)(4).

• Brand Name: TAN/FAN RADILUCENT DROP
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10177292
• Report Number: 1020279-2020-02628
• Device Sequence Number: 2153547
• Product Code: HSB
• UDI-Device Identifier: 03596010604880
• UDI-Public: 03596010604880
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71631022
• Device Catalogue Number: 71631022
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 06/21/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention