MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 7.0MM COMP SCREW STARTER DRILL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674570

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2020

Event Type  malfunction  

Event Description

It was reported that a intertan 7.0mm compression screw starter drill has dulled with repeat use and requires replacing.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Investigation results: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.Therefore, product analysis could not be performed at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: INTERTAN 7.0MM COMP SCREW STARTER DRILL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10224397
• MDR Text Key: 197320406
• Report Number: 1020279-2020-02884
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556389393
• UDI-Public: 00885556389393
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71674570
• Device Catalogue Number: 71674570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1