MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO,DRVR,EXTENDED, BIOSURE, RATCHETED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72202475
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biosure driver shaft had become twisted whilst trying to insert a biosure ha screw into the tibia.The handle itself had remained intact but the extended shaft has twisted.The surgery was completed using a different technique.
Additional Manufacturer Narrative
One 72202475 ratcheted biosure extended driver returned.This is a reusable made to order instrument.The complaint reported: ¿it was reported that the biosure driver shaft had become twisted whilst trying to insert a biosure ha screw into the tibia.The handle itself had remained intact but the extended shaft has twisted.¿ the instrument shows damage at the distal tip only.There is no apparent damage to the shaft or hudson end.The channeled tip has attained damage from excess torque applied.There are ding marks from contact with another instrument or device.The channels are twisted and the tip is bent at the same location.These are representative of loss of axial alignment.Excessive forces applied to the instrument can result in instrument failure.No root cause related to the manufacture of the device was established.Further.

• Brand Name: MTO,DRVR,EXTENDED, BIOSURE, RATCHETED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7396075
• Report Number: 1219602-2018-00400
• Device Sequence Number: 1740844
• Product Code: LXH
• UDI-Device Identifier: 00885554016741
• UDI-Public: (01)00885554016741(10)50586169
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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 Model Number: 72202475
• Device Catalogue Number: 72202475
• Device Lot Number: 50586169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1