MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STD DRILL GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71654502

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Event Description

It was reported that, during internal fixation surgery, the surgeon stated that it was difficult to line up properly a guide bolt (case: (b)(6)) and a std drill guide (case: (b)(6)) during the case.A surgical delay of approximately 2 minutes occurred due to this issue, and a smith and nephew backup devices were available to conclude the procedure.No patient injury was reported due to this issue.

Manufacturer Narrative

The associated device, intended to use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed 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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection was performed and confirmed the stated failure.The standard drill guide posts are worn and damaged, the threads are also showing wear.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint, however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: STD DRILL GUIDE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11962531
• MDR Text Key: 255046478
• Report Number: 1020279-2021-05054
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010585837
• UDI-Public: 03596010585837
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2021

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: 71654502
• Device Catalogue Number: 71654502
• Device Lot Number: 14BSP0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 07/28/2021; 10/12/2021
• Supplement Dates FDA Received: 07/29/2021; 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1