MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE RATCHET DRIVER; SCREW, FIXATION, BONE

Model Number	72201888
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the tip of the screw driver flare up due to it was necessary to put too much torque on the screw.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
One 72201888 biosure cannulated hudson end ratchet driver reported on.This is a three year old reusable instrument.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: condition the driver¿s bit or chuck.Stripping or over-torque use.Getting entangled up with other instruments or devices.Damaged or use of other than recommended prep instrument size or types.Debris such as bone chips caught in the bit or chuck.Unexpected bone density/condition.Final product met predetermined specifications upon release to distribution.
Additional Manufacturer Narrative
One 72201888 biosure cannulated hudson end ratchet driver returned.It is a four year old reusable instrument.The shaft is straight and the hudson end is not damaged.The flutes are in good condition.The distal tip has attained damage.It is flared and out of round.The product has been used with excess torque which may occur from use of an inadequate sized tap or hard bone.It is recommended for the biosure screws that a tap 1 mm larger than the screw size be used.Condition and confirmation of proper function of driver bit and chuck may contribute to the symptom.Debris such as bone chips caught in the bit or chuck may contribute to non concentric drill spin.No root cause related to the manufacture of this device was confirmed.

• Brand Name: BIOSURE RATCHET DRIVER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7995805
• Report Number: 1219602-2018-01429
• Device Sequence Number: 13780802
• Product Code: HWC
• UDI-Device Identifier: 03596010615442
• UDI-Public: (01)03596010615442(10)50543962
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2019

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
• Operator of Device: Health Professional
• Device Model Number: 72201888
• Device Catalogue Number: 72201888
• Device Lot Number: 50543962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/15/2018; 05/22/2019
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/16/2018; 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1