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

Model Number 7207677

Device Problem Material Separation (1562)

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

Event Date 07/06/2020

Event Type  Injury  

Event Description

It was reported that during an acl surgery, the biorci-ha screw broke while being inserting in the tunnel.All pieces were removed.The procedure was completed without significant delay using a back-up device in the same bone hole.It is unknown if all pieces were recovered from the patient.No patient injury or other complications were reported.

Manufacturer Narrative

H3,h6: the reported 7207677 scr biorci-ha 7x30 7mm head sterile, intended for use in treatment, has not been returned for evaluation.Without the reported product, a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, ¿during an acl surgery, the biorci-ha screw broke while being inserting in the tunnel¿.An exact root cause cannot be determined with confidence.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was performed, no other complaints of this failure was found.Further investigation is not warranted at this time.

Manufacturer Narrative

Internal complaint reference (b)(4).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 revealed that the distal tip of the device had fractured off.There was some deformation around the fracture.There was minimal debris.Based on the condition of the product material found during visual inspection it was determined that additional material testing is 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 a repeat issue.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the polymer found that the storage protocols, material specifications, and material tests were appropriately documented.The complaint was confirmed.Factors that could have contributed to the reported event include off-axis insertion, excessive force or bending during use, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

• Brand Name: SCR BIORCI-HA 7X30 7MM HEAD STERILE
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10322085
• MDR Text Key: 200281548
• Report Number: 1219602-2020-01130
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010459923
• UDI-Public: 03596010459923
• Combination Product (y/n): N
• PMA/PMN Number: K032224
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: 7207677
• Device Catalogue Number: 7207677
• Device Lot Number: 50622415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention