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 No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  Injury  

Event Description

It was reported that the drill bit broke off in patient, delayed surgery 10 minutes.Drill bit was able to be removed by surgeon.

Manufacturer Narrative

The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.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 road; memphis TN 38116
• MDR Report Key: 8206155
• MDR Text Key: 131712503
• Report Number: 1020279-2018-02951
• 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: 03/02/2019

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: 71674570
• Device Lot Number: 16KNG0028
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 03/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1