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

Catalog Number 71175072

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the tip of the driver broke off.It broke inside the patient and all pieces were recovered.A s+n back-up device was available, however the procedure was finished with the original device.No delay to the procedure or patient affectation.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the driving end of the device fractured off and was not returned.The device was manufactured in 2017 and exhibits signs of extensive wear / usage.The fracture mostly likely occurred due to ductile torsional overload.An overload fracture can occur if the mechanical loads applied to the device exceeds the strength of the material.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.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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9318728
• MDR Text Key: 166408848
• Report Number: 1020279-2019-04034
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556636046
• UDI-Public: 00885556636046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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 Catalogue Number: 71175072
• Device Lot Number: 17EUP0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1