MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN INSTR; INSTRUMENT, BENDING OR CONTOURING

Catalog Number UNKN02500001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/26/2021

Event Type  Injury  

Event Description

It was reported that, during a planned surgery of meta-tan removal, it was difficult to remove the meta-tan nail with an unknown meta-tan lag screw driver ((b)(4)).Therefore, meta-tan lag screw driver was changed to easy out small.The nail was removed, but part of an unknown lag screw ((b)(4)) and the easy out small ((b)(4)) broke inside the patient.All pieces were removed.The procedure was completed with a less than 30 mins delay using the same device.No other complications were reported.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKN TRIGEN INSTR
• Type of Device: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11696244
• MDR Text Key: 246426257
• Report Number: 1020279-2021-03258
• Device Sequence Number: 1
• Product Code: HXP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02500001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention