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

Model Number	7207557
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the process of screwing this device, it loses strength.It was decided to back off the screw of the tunnel, and then, we noticed that it was broken in half, a distal part of the screw was inside the patient and all parts wereremoved from patient.No patient injuries were reported and a smith and nephew backup was available.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.
Additional Manufacturer Narrative
One 7207557 sterile biorci ha 7x25mm screw returned.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 just over one thread below the head which indicate excessive torque factored at that location.As reported, the missing piece; approximately 13 mm was not returned.The star hex is burnished as well as the remaining thread.The product's ifu clearly specifies: "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 for potential failure.The physical condition of the return indicates difficulty with proper insertion.The ifu also 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." no root cause related to the manufacturing of this device was confirmed.

• 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: 7781971
• Report Number: 1219602-2018-01048
• Device Sequence Number: 227899
• Product Code: HWC
• UDI-Device Identifier: 03596010426208
• UDI-Public: (01)03596010426208(17)230301(10)50718067
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2018

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 Model Number: 7207557
• Device Catalogue Number: 7207557
• Device Lot Number: 50718067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 09/13/2018; 10/16/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/16/2018; 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR