MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 125 RAD DRILL GDE DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71674002

Device Problems Loose or Intermittent Connection (1371); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2018

Event Type  malfunction  

Event Description

It was reported that the during procedure 125 degree radiolucent drop failed to hold the lag screw drill sleeve.The lag screw drill sleeve slid out of the drop without the surgeon pressing the release button.No delay or injury reported.A backup device was not available.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.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.We consider this investigation closed.

• Brand Name: 125 RAD DRILL GDE DROP
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8268837
• MDR Text Key: 133793883
• Report Number: 1020279-2019-00243
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010570970
• UDI-Public: 03596010570970
• 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: 04/14/2019

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: 71674002
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 12/31/2018
• Supplement Dates FDA Received: 04/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1