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 Patient Involvement (2645)

Event Date 07/30/2020

Event Type  malfunction  

Event Description

It was reported that the sealing material on the drill guide handle is cracking. No case involved.

Manufacturer Narrative

Results of investigation: the device, intended for use in treatment, was not returned for evaluation. Therefore, product analysis could not be performed at this time. So the reported event could not be confirmed. A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions. 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, the need for corrective action is not indicated. Without the actual product involved and/or device information, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. No further investigation 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks rd.; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10447657
• Report Number: 1020279-2020-04178
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560469
• UDI-Public: 03596010560469
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71674001
• Device Catalogue Number: 71674001
• Device Lot Number: 4895315403321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse