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

Model Number	7207918
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lca reconstruction by arthroscopy, the device tip broke inside the patient.All pieces were removed.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported 8x20mm biorci screw, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the screw broke during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper site preparation.Excessive force placed on the screw during insertion.The instruction for use were reviewed and were found to outline 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.
Additional Manufacturer Narrative
H10 h3, h6: the reported 8x20mm biorci screw, used in treatment, was returned for evaluation.Visual assessment of the screw confirmed the reported breakage.Approximately 1mm of the distal threads have broken off and were not returned for examination.Dimensional assessment of the screws major diameter and wall thickness was performed and found to meet print specification.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not preparing the insertion site properly.Incorrect screw size to tunnel size.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, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BIORCI SCRW 8MM X 20MM STRL
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9120928
• Report Number: 1219602-2019-01175
• Device Sequence Number: 16672428
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2023
• Device Model Number: 7207918
• Device Catalogue Number: 7207918
• Device Lot Number: 50725427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 10/25/2019; 04/10/2020
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/30/2019; 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1