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

Model Number 7207676

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event 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.

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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9644225
• MDR Text Key: 176872383
• Report Number: 1219602-2020-00147
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010459947
• UDI-Public: 03596010459947
• Combination Product (y/n): N
• PMA/PMN Number: K002274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1