MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIO RCI 10X25MM STRL BX1; SCREW, FIXATION, BONE

Model Number	7207566
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a knee procedure, the bio rci broke while inserting it into the tibial tunnel.There was a backup device available.No significant delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: one sterile biorci 10x25mm screw used for treatment, was not returned for evaluation.Due to product unavailability, evaluation and investigation were limited.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: 1.Site prep with alternate type or recommended size instruments.2.Not accounting for taper or stepped head to body size difference.3.Entanglement with guide wire or other instrument causing tearing and fractures.4.Use of disproportionate screw size.5.Over torqued or use of force causing stripping, fracture 6.Unexpected bone density/condition.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.Complaint history review indicated no similar allegations for the lot number reported.Dhr/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: SCREW BIO RCI 10X25MM STRL BX1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9478584
• Report Number: 1219602-2019-01569
• Device Sequence Number: 18896789
• Product Code: HWC
• UDI-Device Identifier: 03596010435477
• UDI-Public: 03596010435477
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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: 02/07/2024
• Device Model Number: 7207566
• Device Catalogue Number: 7207566
• Device Lot Number: 50786202
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1