MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTI ROTATION BAR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674041

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2020

Event Type  Injury  

Event Description

It was reported that during a trauma procedure the anti rotation bar got caught after inserting the lag screw, upon trying to remove the device using a mallet (this is not indicated to be used in the surgical technique), the handle broke off (mechanical failure of an instrument).No fragments fell into the patient, the part of the device that broke was outside of the patient at the time.This was a trigen intertan procedure for a femoral fracture.All parts were removed and case continued and was completed as normal.A less than 30 min delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Results of investigation: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The handle fractured off the device at the weld joint, rendering it inoperable.All pieces were returned.The device was manufactured in 2008 and shows signs of extensive use.The clinical/ medical investigation concluded that, per complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event that does not represent a device malfunction.Three photos of the device were provided that confirm the failure.Based on the information provided, the procedure change/subsequent modified procedure, and the reported less than thirty-minute procedural delay did not result in patient injury/impact; therefore, since all parts were reportedly recovered and the case completed as normal, no further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.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.We consider this investigation closed.

• Brand Name: ANTI ROTATION BAR
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10382276
• MDR Text Key: 202164436
• Report Number: 1020279-2020-03789
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010605238
• UDI-Public: 03596010605238
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71674041
• Device Catalogue Number: 71674041
• Device Lot Number: 08CCT0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention