MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 9X30MM STRL BX 1; SCREW, FIXATION, BONE

Catalog Number	7207564
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unspecified surgery, the biorci screw broke while inserting in the tibia.It is unknown whether all fragments were retrieved from the patient.A back-up device was available to complete the procedure, but it is unknown if an additional bone hole had to be drilled.The surgery was not significantly delayed.The patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One sterile biorci ha 9x30mm 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.Instructions for use confirms instructions, recommendations and precautionary statements for proper use of product.Influences that could compromise product integrity include: use of damaged or other than recommended prep instrument size and/or types.Not accounting for taper or larger head to body design.Entanglement with guide wire or other instrument causing tearing and fractures.Unexpected bone density/condition.Use of excess torque or force.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Prep per the instructions for use recommendation is critical for ease of insertion and successful anchoring.Per instructions for use: ¿read these instructions completely prior to use.The starter must be utilized with the biorci screws to minimize screw breakage during insertion.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.If using a 7 mm biorci 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.Excessive force should not be placed on the delivery instrument.Final product met specifications upon release to distribution.

• Brand Name: SCR BIORCI 9X30MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9294047
• Report Number: 1219602-2019-01388
• Device Sequence Number: 2362416
• Product Code: HWC
• UDI-Device Identifier: 03596010426260
• UDI-Public: 03596010426260
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K992396
• 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): 12/10/2019

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: 08/24/2023
• Device Catalogue Number: 7207564
• Device Lot Number: 50754825
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1