MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORCI SCRW 7MM(7MM HD)X20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	7207916
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgical procedure, at the moment of placing the screw in the femoral tunnel, it broke in half with the tip of the screw inside the patient, so with the help of a tweezer, the remains of the screw were completely removed, this generated a delay and the need to place another screw of the same reference.No patient injury was reported.
Additional Manufacturer Narrative
One (b)(4) biorci 7x20mm 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.Getting entangled up with other instruments or devices.3.Stripping or over-torque.4.Damaged prep instruments.5.Unexpected bone density/condition.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.No further investigation is warranted at this time.
Additional Manufacturer Narrative
Additional information.One biorci 7x20mm screw returned.The complaint stated: ¿at the moment of placing the screw in the femoral tunnel, it broke in half with the tip of the screw inside the patient.¿ the product was fractured.It was also severed vertically.The conditions are consistent with excess torque applied and entanglement with a guidewire or other instrument.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Prep 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.¿.

• Brand Name: BIORCI SCRW 7MM(7MM HD)X20MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8148456
• Report Number: 1219602-2018-01697
• Device Sequence Number: 1439413
• Product Code: MAI
• UDI-Device Identifier: 03596010000897
• UDI-Public: 03596010000897
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K032224
• 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): 03/26/2019

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: 04/06/2023
• Device Catalogue Number: 7207916
• Device Lot Number: 50725426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 01/10/2019; 03/25/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/11/2019; 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1