MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 10MM X 30MM; SCREW, FIXATION, BONE

Catalog Number	72201786
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, when the screw was being inserted, the tip broke.A backup device was used to complete the procedure with no surgical delay or patient injuries.
Additional Manufacturer Narrative
One biosure 10x30mm ha screw reported on.Product was used for treatment but was not returned for evaluation.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were limited 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: unexpected bone density/condition.Site prep with alternate type or recommended size instruments.Stripping or over-torque.Getting entangled up with other instruments or devices.Damaged prep instruments.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Prep per the instruction for use recommendation is critical for ease of insertion and successful anchoring.Per instruction for use: ¿the starter must be utilized with the biorci screws to minimize screw breakage during insertion.Prior to use inspect the tip of the driver.If tip flaring is apparent do not use the driver.Excessive force should not be placed on the delivery instrument.In cases where hard bone is encountered, it is recommended that a tap 1 mm larger than the screw size be used.¿ final product met specifications upon release to distribution.Health professional: no, occupation should not be marked.Health professional should not be marked and company representative should be marked.
Additional Manufacturer Narrative
One 72201786 biosure 10x30mm ha screw used for treatment, was returned for evaluation.Dimensional inspection verified that this was a 10x30mm product.Approximately a half mm of distal tip is absent.The tip was chewed up.It was fractured from resistance as with hard bone or inadequate tunnel diameter.The head of the screw displayed no damage.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: unexpected bone density/condition.Site prep with alternate type or recommended size instruments.Instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Prep per the instructions for use recommendation is critical for ease of insertion and successful anchoring.Per instructions for use: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.The starter must be utilized with the biorci screws to minimize screw breakage during insertion.Prior to use inspect the tip of the driver.If tip flaring is apparent do not use the driver.Ensure the screw is seated fully onto the tip of the screwdriver.Excessive force should not be placed on the delivery instrument.In cases where hard bone is encountered, it is recommended that a tap 1 mm larger than the screw size be used.¿ no root cause related to the manufacturing of this device was confirmed.Final product met specifications upon release to distribution.

• Brand Name: BIOSURE HA 10MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8915157
• Report Number: 1219602-2019-00997
• Device Sequence Number: 11215515
• Product Code: HWC
• UDI-Device Identifier: 03596010611826
• UDI-Public: 03596010611826
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2019

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 Expiration Date: 08/09/2023
• Device Catalogue Number: 72201786
• Device Lot Number: 50752148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 09/24/2019; 11/12/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/26/2019; 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1