MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 7X25 7MM HEAD STERILE; SCREW, FIXATION, BONE

Model Number 7207674

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/10/2019

Event Type  malfunction  

Event Description

It was reported that during an acl reconstruction surgery the scr biorci-h screw was found fractured when it was screwed-in.Broken pieces were retrieved from the patient using tweezers the procedure was successfully completed without a 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

H10.H3, h6: the reported 7x25mm biorci ha screw, used in treatment, was returned for evaluation.Visual assessment of the screw confirmed the reported breakage.Approximately 2.5mm of the distal threads have been broken off and were not returned for examination.Dimensional assessment of the screws major diameter and wall thickness was measured and found to meet print specification.Without the pertinent clinical details an exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.Not preparing the insertion site with the proper prep device.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SCR BIORCI-HA 7X25 7MM HEAD STERILE
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9591829
• MDR Text Key: 175068930
• Report Number: 1219602-2020-00094
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010459916
• UDI-Public: 03596010459916
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2023
• Device Model Number: 7207674
• Device Catalogue Number: 7207674
• Device Lot Number: 50762648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 80