MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 9X25MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207563
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zipcode (b)(6).
Event or Problem Description
It was reported that, during an acl reconstruction, while inserting the biorci screw into the tibial bone tunnel, it broke.Fragments were removed from the patient using tweezers.There was a backup device available.No significant delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h6.The reported 9x25mm biorci screw, used 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: 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.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The reported 9x25mm biorci screw, used in treatment, has been returned for evaluation.Visual assessment of the screw confirmed the reported breakage.Approximately 2mm of the distal threads have been broken off and were not returned.Dimensional assessment of the screws major diameter and wall thickness was performed and found to meet print specifications.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 complaint records was performed for the reported device lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SCR BIORCI 9X25MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9819679
• Report Number: 1219602-2020-00505
• Device Sequence Number: 3068838
• Product Code: HWC
• UDI-Device Identifier: 03596010426253
• UDI-Public: 03596010426253
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2024
• Device Model Number: 7207563
• Device Catalogue Number: 7207563
• Device Lot Number: 50779636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 07/02/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/14/2020; 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1