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

Model Number 71674001

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that, the bowed of a drill guide handle split and that pieces were falling/crumbling out.Incident occurred during a spd audit.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was returned for evaluation.Our investigation included a visual inspection of the device which confirms that the epoxy coating over the internal witness wire has degraded and has begun to come off.This failure mode has been previously identified.Since the manufacturing of the complaint device, design changes have been implemented to eliminate the occurrence of this failure.The device was manufactured in 1995.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, corrective and preventive action is indicated to mitigate future recurrence of similar events.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.We consider this investigation closed.

• Brand Name: DRILL GUIDE HANDLE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11326560
• MDR Text Key: 231958855
• Report Number: 1020279-2021-01305
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560469
• UDI-Public: 03596010560469
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71674001
• Device Catalogue Number: 71674001
• Device Lot Number: 489531 OR 5403321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1