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

Catalog Number 71674570

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 11/09/2018

Event Type  malfunction  

Event Description

It was reported that the item broke during case.The drill broke off at the tip in the wound but was easily retrieved and nothing was left inside the patient.

Manufacturer Narrative

The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.A review of complaint history for the listed part revealed prior complaints for the listed failure mode.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.

• 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 road; memphis TN 38116
• MDR Report Key: 8119218
• MDR Text Key: 128870450
• Report Number: 1020279-2018-02633
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71674570
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1