MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN LAG SCREW DRILL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674040

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the screw drill interfered with something inside the patient, so the device was removed from the surgical field and it was found the tip on the device was missing.Any piece was found on the x ray image.15 minutes delay reported.

Manufacturer Narrative

The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The tip of the drill was heavily damaged and some small pieces fractured off the tip.The fractured pieces were not returned.The guide pins were heavily worn and bent with score marks on the shafts.The devices were manufactured in 2014, 2018 and 2019 and show signs of extensive wear / usage.The medical investigation concluded that, based on the results of the product evaluation, the root cause of the reported tip breakage is likely due to ¿extensive wear / usage¿ factor along with the interference with the guide pin.The 465 stainless steel is not an implantable alloy; therefore, long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, local irritation/discomfort, and probable mri restrictions cannot be determined.No further medical assessment can be rendered at this time.A review of complaint history did not reveal additional complaints for the listed batches.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.This device is a reusable instrument 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 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: INTERTAN LAG SCREW DRILL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9528943
• MDR Text Key: 175115321
• Report Number: 1020279-2019-04624
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010596994
• UDI-Public: 03596010596994
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: 71674040
• Device Catalogue Number: 71674040
• Device Lot Number: 14BNG0019
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71631436 GUIDE PIN 3.2MM X 343MM .B#19GSM0351.; 71631436 GUIDE PIN 3.2MM X 343MM. B#18JSM0248.; 71631436 GUIDE PIN 3.2MM X 343MM. B#19FSM0478.; 71631436/GUIDE PIN 3.2MM X 343MM.