MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 8X25 STERILE; SCREW, FIXATION, BONE

Model Number 7207678

Device Problem Material Separation (1562)

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

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

The reported 8x25mm biorci screw, used in treatment, has been returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 12mm of the distal threads have broken off and were not returned for examination.Dimensional assessment of the screw major diameter and wall thickness was performed and confirmed to meet print specification.Without the pertinent clinical details regarding graft type, tunnel size and patient bone quality an exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not using a starter or a tap in hard bone applications.Not preparing the tibial and femoral tunnels in accordance with the accepted surgical technique.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 complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

Event Description

It was reported that during an acl surgery the biorci had a manufacture defect, it was broken, the device did not broke inside the patient's anatomy.No patient injuries or significant delay reported.Back-up device was available to complete the surgery.Results of investigation have concluded that this unit broke intra-operatively which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SCR BIORCI-HA 8X25 STERILE
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 9638865
• MDR Text Key: 176664033
• Report Number: 1219602-2020-00140
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010459961
• UDI-Public: 03596010459961
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K002274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: 7207678
• Device Catalogue Number: 7207678
• Device Lot Number: 50718204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR