MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 8X35 STERILE; SCREW, FIXATION, BONE

Model Number	7207680
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an ligamentoplasty, 3 biorci-ha screws broke outside patient.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.It was determined the device did not contribute to the reported event.A visual inspection of the returned device found that it is not in its original packaging.The screw is fractured on the distal end, and there is debris in the threads.Based on the condition of the product material found during visual inspection, additional material testing is not required.The complaint was confirmed, and the root cause was associated with unintended use of the device.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A review of risk management files found that the reported failure was documented appropriately.A review of the polymer found found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: SCR BIORCI-HA 8X35 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12572803
• Report Number: 1219602-2021-02196
• Device Sequence Number: 11808622
• Product Code: HWC
• UDI-Device Identifier: 03596010459985
• UDI-Public: 03596010459985
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K002274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2021

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: 04/03/2024
• Device Model Number: 7207680
• Device Catalogue Number: 7207680
• Device Lot Number: 50797845
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown