MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 10X30 STERILE; SCREW, FIXATION, BONE

Model Number	7209017
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction surgery, the anchor broke while being inserted, broken pieces were removed using a mosquito grasper.The procedure was completed with a back up device with no significant delay or patient injury reported.
Additional Manufacturer Narrative
One 7209017 sterile biorci ha 10x30mm screw was used for treatment but was not returned for evaluation.Due to product unavailability, evaluation, investigation and conclusions 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 and for proper use of product.Influences that could compromise product integrity include: 1.Site prep with alternate or without recommended instruments.2.Screw taper style or larger head to body design unaccounted for.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 biorciscrews 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.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
H10.H3, h6: one biorci ha 10x30mm screw used for treatment, was returned for evaluation.These are an interference fit screw product recommended for acl or pcl procedures.The item was returned fractured.There was approximately 4mm distal material absent from the tip.There are light scuff marks inside the cannula and hex head.This is typical of stripping or guide wire damage.Pressure and force was a contribution to the fracture.Prep specific to this product is recommended.Per instructions 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¿ha screws to minimize screw breakage during insertion.If hard bone is encountered, the biorci tap should be used.With interference style screws, use of same size tunnel allows screw threads to make optimum surface to surface.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.No root cause associated with the manufacture of this device was confirmed.Product met specifications upon release to distribution.

• Brand Name: SCR BIORCI-HA 10X30 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9150828
• Report Number: 1219602-2019-01195
• Device Sequence Number: 19484726
• Product Code: HWC
• UDI-Device Identifier: 03596010460042
• UDI-Public: 03596010460042
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002274
• 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,Followup
• Report Date (Section B): 02/03/2020

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: 04/03/2024
• Device Model Number: 7209017
• Device Catalogue Number: 7209017
• Device Lot Number: 50797843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 10/31/2019; 01/31/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/01/2019; 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1