MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 130 RAD DRILL GDE DROP; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number 71674003

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/27/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the captured distal screws were not aligning properly.A s&n backup device was available but not used to finish the surgery, fluoroscope was performed to finish the surgery.No delay nor injury was reported.

Manufacturer Narrative

Additional information: b5 the associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The devices were manufactured in 2016 and show signs of extensive wear / usage.A dimensional / functional inspection could not confirm the stated failure mode.The devices were found to functional as intended and passed all the required gaging.A review of complaint history did not reveal additional complaints for the listed batches for the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.These devices are reusable instruments that can be exposed to numerous surgeries.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 complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

Event Description

It was reported that during surgery the captured distal screws were not aligning properly.S&n backup device was available but not used, technique without the guide and fluoroscopy was performed to finish the surgery.No delay nor injury was reported.No medical intervention was required.

• Brand Name: 130 RAD DRILL GDE DROP
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9528273
• MDR Text Key: 177212909
• Report Number: 1020279-2019-04613
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 03596010560476
• UDI-Public: 03596010560476
• 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: 02/25/2020

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 Model Number: 71674003
• Device Catalogue Number: 71674003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2020
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/28/2019
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1