MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 9MM X 25MM; SCREW, FIXATION, BONE

Catalog Number 72201781

Device Problems Break (1069); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2019

Event Type  malfunction  

Event Description

It was reported during an acl procedure, there was a breaking and screwing in the key due to the defective contact of the device with the bone of the patient.All the fragments were totally removed.A backup device was available to complete the procedure with no delay and no patient injuries.

Manufacturer Narrative

One biosure ha 9x25mm 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: 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.

• Brand Name: BIOSURE HA 9MM X 25MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; BA 78735 ; 5123585706
• MDR Report Key: 8344080
• MDR Text Key: 136592835
• Report Number: 1219602-2019-00210
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010611772
• UDI-Public: 03596010611772
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K080358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2023
• Device Catalogue Number: 72201781
• Device Lot Number: 50752140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1