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

Model Number 71674001

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

It was reported that the drill guide handle is cracked.S&n backup available.No delay to surgery or injury to patient reported due to this.

Manufacturer Narrative

Internal complaint reference (b)(4).Results of investigation: the device, used 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.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.Expected wear/tear is likely the probable cause 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.

• 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: 10687673
• MDR Text Key: 211631788
• Report Number: 1020279-2020-05455
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: 08HGT0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2020
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1