MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 10X25 STERILE; SCREW, FIXATION, BONE

Catalog Number	7209016
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, screw broke while deploying.The procedure was successfully completed with no significant delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported 10mm x 25mm biorci ha intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided: the screw broke during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper preparation of the insertion site.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
One 10x25 biorci-ha screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint.The screw is cracked at its first distal thread.The condition of the screw indicates it was likely subjected to excessive force.The clinical details provided were reviewed, and it was identified that there was no mention of the insertion site being prepared with a starter.

• Brand Name: SCR BIORCI-HA 10X25 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8628895
• Report Number: 1219602-2019-00586
• Device Sequence Number: 11176517
• Product Code: HWC
• UDI-Device Identifier: 03596010460035
• UDI-Public: 03596010460035
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2019

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: 06/20/2023
• Device Catalogue Number: 7209016
• Device Lot Number: 50742693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/19/2019; 07/08/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/20/2019; 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1