MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 10X30MM STRL BX 1; SCREW, FIXATION, BONE

Catalog Number	7207567
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of screw broke during insertion.Biorci screw 11x30mm used as an alternative.No patient injury was reported.
Additional Manufacturer Narrative
Additional information.One (b)(4) sterile biorci 10x30mm 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: 1.Use of other than recommended prep instrument size or types.2.Entanglement with guide wire or other instrument.3.Stripping or over torque.4.Damaged prep instruments.5.Not accounting for taper or larger head to body design.6.Unexpected bone density/condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Preparation per the instruction for use recommendation is critical for ease of insertion and successful anchoring.Per instruction for use: ¿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.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.If hard bone is encountered, the biorci tap should be used.¿ final product met specifications upon release to distribution.Corrected information.
Event or Problem Description
It was reported that, suring an unknown surgery, the tip of screw broke during insertion.It is unknown whether the fragments were retrieved from the patient.A biorci screw 11x30 mm used as an alternative.No significant surgical delay happened.No patient injury was reported.

• Brand Name: SCR BIORCI 10X30MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8155650
• Report Number: 1219602-2018-01739
• Device Sequence Number: 19234006
• Product Code: HWC
• UDI-Device Identifier: 03596010426284
• UDI-Public: 03596010426284
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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: Physician
• 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: 02/05/2023
• Device Catalogue Number: 7207567
• Device Lot Number: 50712646
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• 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