MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LARGE SCREWDRIVER HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71173547

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2019

Event Type  malfunction  

Event Description

It was reported that large screw driver handle (cannulated) got jammed.The tech used pliers to loosen the driver but dr.Had to complete the screw removal by hand rather than switching to power as he did on the previous screw removals.The patient was not affected and loss of time was less than one minute.A 30 min delay was reported.No more information provided yet.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2016 and exhibits signs of extensive wear/usage.The functional evaluation could not confirm the stated failure mode.The device functioned as intended with a mating part.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LARGE SCREWDRIVER HANDLE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8920298
• MDR Text Key: 155194033
• Report Number: 1020279-2019-03115
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010519580
• UDI-Public: 03596010519580
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71173547
• Device Lot Number: 16BTMH017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1