MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1; SCREW, FIXATION, BONE

Catalog Number	7207557
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw was broken inside the tunnel.Pieces were removed from patient.Minimal delay was reported and backup was available to complete the procedure.No patient injuries were reported.
Additional Manufacturer Narrative
One (b)(4) sterile biorci ha 7x25mm screw returned.The complaint reported: ¿when the screw advanced 10mm inside the femoral tunnel, it broke.¿ dimensional inspection confirmed that this was a 7x25mm screw.This product has an 8mm head which requires consideration when preparing the bone tunnel.The diameter needs to accommodate the 8mm head.The screw was broken at approximately 16mm from the hex end.There was no damage to the hex.The screw was fractured and jagged with approximately 8.7mm material missing.The damage indicated excessive torque was a factor.It is also possible that entanglement with another instrument or device caused the jagged end.If using a 7 x 25 mm screw with an 8 mm head, it is essential to use a stepped router during drilling in order to provide an adequate space for both the head of the screw and the graft.This counter bore is necessary to create space which will accommodate the 8mm screw head and the graft.If there is not sufficient space for the head and graft, force then becomes a factor contributing to potential failure.The physical condition of the return indicates difficulty with proper insertion.Excessive force should not be placed on the delivery instrument.No root cause related to the manufacturing of this device was confirmed.
Additional Manufacturer Narrative
One 7207557 sterile biorci 7x25mm 8mm head screw reported on.Due to product unavailability, physical evaluation, full investigation and conclusions were not possible.Factors affecting device performance include: device ability, surgical ability and surgical site preparation according to instructions for use (ifu).Ifu confirms instructions, recommendations and precautionary statements and for proper use of product.Influences that could compromise product integrity include: site prep with alternate type or recommended size instruments.Not accounting for taper or stepped head to body size difference.Entanglement with guide wire or other instrument causing tearing and fractures.Use of disproportionate screw size.Over torqued or use of force causing stripping, fracture.Unexpected bone density/condition.Final product met predetermined specifications upon release to distribution.Additional information.Correction in: yes health care professional.Health professional and user facility should be marked.Company representative should be blank.
Event or Problem Description
It was reported that when the screw advanced 10mm inside the femoral tunnel, it broke.Pieces were removed from patient.Minimal delay was reported and the procedure was completed by fixing the ligament in the tibia with a 10x35mm biorci screw without any problem.No patient injuries were reported.

• Brand Name: SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8028675
• Report Number: 1219602-2018-01481
• Device Sequence Number: 16469592
• Product Code: HWC
• UDI-Device Identifier: 03596010426208
• UDI-Public: 03596010426208
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K992396
• 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): 02/26/2019

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: 03/01/2023
• Device Catalogue Number: 7207557
• Device Lot Number: 50718067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 12/19/2018; 02/25/2019
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/20/2018; 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR