MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE; HELMET, SURGICAL

Model Number 71174934

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2020

Event Type  malfunction  

Event Description

It was reported that during surgery 2.0/2.7mm double-ended drill guide broke during the procedure.All pieces were recovered from the patient.The procedure was successfully completed without delay using an smith & nephew back up device.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The 2.0 drill sleeve on the device is missing, rendering the device inoperable.The device was manufactured in 2014 and shows signs of extensive wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.

• Brand Name: 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE
• Type of Device: HELMET, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9952984
• MDR Text Key: 187867608
• Report Number: 1020279-2020-01276
• Device Sequence Number: 1
• Product Code: FXZ
• UDI-Device Identifier: 00885556387993
• UDI-Public: 00885556387993
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 71174934
• Device Catalogue Number: 71174934
• Device Lot Number: 14KTD0001
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1