MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 7X30 8MM HEAD STERILE; SCREW, FIXATION, BONE

Model Number	7207676
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported about a screw, biorci-ha 7/8 x 30 mm that during an unknown procedure while it was being deployed, the screw got broken.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were 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 7207676 sterile biorci ha 7x30mm screw used for treatment, was not returned for evaluation.Due to product unavailability, investigation was limited.Factors affecting device performance include: device ability, surgical ability and surgical site preparation according to instructions for use.Instructions for use contains recommendations and precautionary statements for proper use of product.Influences that could compromise product integrity include: 1.Use of damaged or other than recommended prep instrument size and/or types.2.Not accounting for taper or larger head to body design.3.Entanglement with guide wire or other instrument causing tearing and fractures.4.Unexpected bone density/condition.5.Use of excess torque or force.Prep per the instructions for use recommendation is critical for ease of insertion and successful anchoring.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 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.¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.No additional actions required at this time.

• Brand Name: SCR BIORCI-HA 7X30 8MM HEAD STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9644225
• Report Number: 1219602-2020-00147
• Device Sequence Number: 1964773
• Product Code: HWC
• UDI-Device Identifier: 03596010459947
• UDI-Public: 03596010459947
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 03/27/2020
• Device Model Number: 7207676
• Device Catalogue Number: 7207676
• Device Lot Number: 50543460
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1