MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.5MM HEX LINEAR DRIVER SHAFT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71175098
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the proximal tibia the doctor used an evos 8h lateral proximal tibia plate.When doctor inserted the most distal screw on power (percutaneous), then final tightened on hand the screw stripped.
Additional Manufacturer Narrative
The associated complaint devices were returned for evaluation.A visual assessment of the devices confirmed the stated failure.The hex end of the driver shaft was rounded and the prongs on the capture sleeve were damaged/bent.The device exhibits signs of significate wear/usage.A review of complaint history did not reveal any additional complaints for the listed batch for the same failure mode.We recommend that all re-usable instruments be routinely inspected for wear/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.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: 2.5MM HEX LINEAR DRIVER SHAFT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7875161
• Report Number: 1020279-2018-01785
• Device Sequence Number: 16191040
• Product Code: MDM
• UDI-Device Identifier: 00885556651339
• UDI-Public: 00885556651339
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71175098
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 11/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization