MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 7MM X 20MM; SCREW, FIXATION, BONE

Catalog Number	72201771
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the screw broke while inserting.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
One 72201771 7x20mm biosure ha screw used for treatment, was returned for evaluation.The complaint stated: ¿the screw broke while inserting.¿ there was a relationship between the reported event and the device.Dimensional inspection confirmed that this was a 7x 20mm product.The distal threads have been burnished and compressed from force and pressure.This would indicate force and over-torque.Prep per the instructions for use recommendation is critical for ease of insertion and successful anchoring.The instructions for use says: ¿excessive force should not be placed on the delivery instrument¿ and ¿the starter must be utilized with the biorci screws to minimize screw breakage during insertion.¿ it is unknown whether recommendations were followed.Details such as type and size of tap, size of tunnel drilled, procedure conducted and patient bone condition were not included.The physical condition indicates difficulty with proper insertion.No root cause related to the manufacturing of this device can be confirmed.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
One 72201771 7x20mm biosure ha screw reported on.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: 1.Use of other than recommended prep instrument size or types 2.Entanglement with other instruments or devices.3.Stripping or over-torque.4.Recommendations not adhered to.5.Damaged prep instruments.6.Unexpected bone density/condition.Documentation confirms instructions, precautionary statements and recommendations for proper use of product.Recommendation is critical for ease of insertion and successful anchoring.¿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.

• Brand Name: BIOSURE HA 7MM X 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8601452
• Report Number: 1219602-2019-00538
• Device Sequence Number: 13952649
• Product Code: HWC
• UDI-Device Identifier: 03596010611673
• UDI-Public: 03596010611673
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2019

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: 04/20/2023
• Device Catalogue Number: 72201771
• Device Lot Number: 50728839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 06/24/2019; 07/17/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/24/2019; 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1