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

Model Number	71631022
Medical Device Problem Codes	Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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
The device, used in treatment, was returned for evaluation.A visual inspection confirmed the device shows significant signs of wear/usage.A functional evaluation of the returned device cannot confirm the stated failure mode.The device will require dimensional evaluation.A dimensional evaluation was conducted and confirms per inspection of the returned complaint device(s), the radiolucent drop is 10 years old and exhibits signs of significant wear/usage - the drill guide is 14 years old and exhibits signs of significant wear/usage.Both parts function as intended.Nothing was detected or determined to be a cause of why the devices are no longer targeting screws correctly.With the parts being as old as they are, it is concluded that the wear/usage on the parts have contributed to the issue stated.A medical investigation was conducted and confirms 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.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• 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: 10177291
• Report Number: 1020279-2020-02627
• Device Sequence Number: 2153546
• 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): 05/17/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/21/2020
• Supplement Report FDA Received Date: 05/17/2021
• 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