MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 7X25 8MM HEAD STERILE; SCREW, FIXATION, BONE

Catalog Number	7207675
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgical procedure when tightening the screw in the femur the same broke and had to be replaced.No back up device was available.
Additional Manufacturer Narrative
Foreign post code - (b)(4).One (b)(4) sterile biorci ha 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, which confirms instructions, recommendations and precautionary statements and for proper use of product.Influences that could compromise product integrity include: 1.Site prep with alternate or without recommended instruments.2.Not accounting for taper or larger head to body design.3.Entanglement with guide wire or other instrument causing tearing and fractures.4.Use of disproportionate screw size.5.Use of excess torque or force.Per instructions for 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.Read these instructions completely prior to use.¿ interference style screws maximum surface-to-surface intent is achieved by use of same size tunnel as product, allowing threads to make optimum surface-to-surface contact.Final product met predetermined specifications upon release to distribution.Corrected information.
Event or Problem Description
It was reported that, during an unknown procedure, the screw in the femur broke when being tighetened, so it had to be replaced with a back-up device.It is unknown if pieces were removed.Neither surgical delay nor patient injuries were stated.

• Brand Name: SCR BIORCI-HA 7X25 8MM HEAD STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8155824
• Report Number: 1219602-2018-01735
• Device Sequence Number: 19364773
• Product Code: HWC
• UDI-Device Identifier: 03596010459930
• UDI-Public: 03596010459930
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K002274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 09/02/2019
• Device Catalogue Number: 7207675
• Device Lot Number: 50518241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1