MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN VLP MINI-MOD SMALL BONE PLATING INSTR; SCREWDRIVER

Catalog Number UNKN02500102

Device Problem Corroded (1131)

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

Event Date 04/05/2021

Event Type  malfunction  

Event Description

It was reported that during a surgery the d-rad smart pack 4h right wide plate had a screw driver, depth and drill bits with rust on them hence the device was not sterile.This happened external to the patient therefore was not injure infringe to the person.This cause a considerable delay of one hour to perform the procedure.The implants were sent for sterilization and re-used on the patient.No other complication were reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN VLP MINI-MOD SMALL BONE PLATING INSTR
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11729610
• MDR Text Key: 247504240
• Report Number: 1020279-2021-03494
• Device Sequence Number: 1
• Product Code: HXX
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02500102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1