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

Catalog Number	72201786
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgical procedure the knee arthroscopy, at the time that the screw was set in the graft it began to loosen the screw thread of the fillets.Additional information was received and was confirmed that the anchor broke inside the patient but all the pieces were removed.
Additional Manufacturer Narrative
One 72201786 biosure 10x30mm 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: 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 10MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8368974
• Report Number: 1219602-2019-00241
• Device Sequence Number: 420033
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 50752146
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR