MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 9X25MM STRL BX 1; SCREW, FIXATION, BONE

Model Number 7207563

Device Problem Material Separation (1562)

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

Event Date 10/19/2020

Event Type  malfunction  

Event Description

It was reported that the scr biorci 9x25mm was broken, identified during the procedure.No patient injury or delay.S&n back-up device used to complete the procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.The customer provided images confirm that device was broken.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force during implementation.Internal complaint reference: case-2020-00024960-1.

Manufacturer Narrative

H10: h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found the tip of the screw has been broken.The customer provided images confirm that device was broken.Based on the condition of the product material found during visual inspection it was determined that additional material testing was not required.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the raw material, found that the material certificate of analysis required.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force or torque, off-axis insertion, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

• Brand Name: SCR BIORCI 9X25MM STRL BX 1
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10813739
• MDR Text Key: 215510180
• Report Number: 1219602-2020-01808
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010426253
• UDI-Public: 03596010426253
• Combination Product (y/n): N
• PMA/PMN Number: K992396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2024
• Device Model Number: 7207563
• Device Catalogue Number: 7207563
• Device Lot Number: 50779633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1