MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM LONG PILOT DRILL; PLATE, FIXATION, BONE

Catalog Number 71631110

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the drill bit was missing from the set.More than 30 minutes delay was reported and the procedure was finished with a competitors device.

Manufacturer Narrative

The associated complaint devices were not returned.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.

• Brand Name: 4.0MM LONG PILOT DRILL
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8643499
• MDR Text Key: 146573091
• Report Number: 1020279-2019-02060
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010392503
• UDI-Public: 03596010392503
• Combination Product (y/n): N
• PMA/PMN Number: K123055
• 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: 11/14/2019

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: 71631110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2019
• Initial Date FDA Received: 05/27/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1