MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR; NAIL, FIXATION, BONE

Model Number 71175072

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the device handle snapped.A s&n backup was available.No delay nor injury was reported.The device broke inside the patient, all the pieces were retrieved.

Manufacturer Narrative

The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.We recommend that all re-usable instruments be routinely inspected for wear damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

Manufacturer Narrative

Updated results of investigation: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The driving tip fractured off the device, rendering it inoperable.The tip was not returned.The device was manufactured in 2017 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 have no 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.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DR
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9330997
• MDR Text Key: 166645203
• Report Number: 1020279-2019-04063
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556636046
• UDI-Public: 00885556636046
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2020

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: 71175072
• Device Catalogue Number: 71175072
• Device Lot Number: 17HUP0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2020
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 10/18/2019; 10/18/2019
• Supplement Dates FDA Received: 12/05/2019; 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1