MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORCI SCRW 8MM X 20MM STRL; SCREW, FIXATION, BONE

Model Number	7207918
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during and anterior cruciate ligament reconstruction, a problem was detected at the time of fixing the graft with the biorci screw.The 8 mm x 20 mm screw did not enter in the grafted space.It was indicated that the screw had a damage in the tip (breakage).The procedure was completed without significant delay using a smaller size screw (7mm x 20mm) as a back-up device and using a 9mm x 20mm screw in the partetibial.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.
Additional Manufacturer Narrative
Additional information on b5: all pieces were removed and no additional bone holes were needed.
Event or Problem Description
It was reported that during and anterior cruciate ligament reconstruction, internal to the patient, a problem was detected at the time of fixing the graft with the biorci screw.The 8 mm x 20 mm screw did not enter in the grafted space.It was indicated that the screw got broken, all pieces were removed.The procedure was completed without significant delay using a smaller size screw (7mm x 20mm) as a back-up device.No additional bone holes were needed.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.
Additional Manufacturer Narrative
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 performed observed that the screw had tip deformation and a missing piece from the thread.Based on the condition of the product material found during visual inspection it was determined that additional material testing is not required.An analysis of the customer provided image found the screw with tip deformation and a missing piece from the thread.A review of the device history records showed there were no indications to suggest that the lot 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 the instructions for use 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 raw materials found that a material certificate of analysis is required.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, off-axis insertion, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

• Brand Name: BIORCI SCRW 8MM X 20MM STRL
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10587071
• Report Number: 1219602-2020-01471
• Device Sequence Number: 2626885
• Product Code: HWC
• UDI-Device Identifier: 03596010485540
• UDI-Public: 03596010485540
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K032224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2025
• Device Model Number: 7207918
• Device Catalogue Number: 7207918
• Device Lot Number: 50849971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 11/04/2020; 05/21/2021
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/05/2020; 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention