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

Catalog Number 71674002

Device Problems Material Deformation (2976); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  malfunction  

Event Description

It was reported that, during a trauma procedure, it was noticed that the following instruments of the trigen¿ intertan¿ instrument set are warped due to wear and tear over past 3 years: lag screw drill sleeve (case-(b)(4)), intertan 3.2mm guide pin sleeve (case-(b)(4)), lag screw tap (case- (b)(4)), lag screw driver (case-(b)(4)), compression screw hexdriver (case-(b)(4)), subtroc lag screw driver (case-(b)(4)), 130 rad drill gde drop (case-(b)(4) ), unknown trigen instrument (case-(b)(4)), unknown trigen instrument (case-(b)(4)).The procedure was able to be completed with the same device.Surgery was greater than 30mins delayed.Patient was not harmed.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be worn and shows signs of wear and tear, rendering the device inoperable.The device shows signs of extensive use.A review of complaint history did not reveal additional 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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.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: 125 RADIOLUCENT DRILL GUIDE DROP
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11861891
• MDR Text Key: 255110573
• Report Number: 1020279-2021-04568
• Device Sequence Number: 1
• Product Code: HSB
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71674002
• Device Lot Number: 07GGT0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1