MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 7X30MM (7MM HEAD) STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207555
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, when the package of the screw biorci was opened, the thread on tip was found to be broken/defective.It is unknown if there was a delay, if backup was available and how the issue was resolved.No patient injury or other complications were reported.Preliminary results of investigation have concluded that this anchor was fractured and had biological debris which makes it a reportable event.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during a procedure, when the package of the screw biorci was opened, the thread on tip was found to be broken/defective.It is unknown if there was a delay, if backup was available and how the issue was resolved.No patient injury or other complications were reported.Results of investigation have concluded that this anchor was fractured and had biological debris which makes it a reportable event.
Additional Manufacturer Narrative
B5 was updated.H6, health effect - clinical code/impact code and medical device problem code were added.H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The distal tip of the screw is fractured, and there is biological debris on the device.Based on the condition of the product material found during visual inspection, additional material testing is not required.The device contributed to the reported event.The complaint was confirmed, the root cause was unintended use of the device.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 inconsistent with normal use.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.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and 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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the resin found that the storage protocols, material specifications, and material tests were appropriately documented.No containment or corrective actions are recommended at this time.Our clinical investigation concluded: it is unknown if any of the broken threads from the anchor remained in the patient following use.If a portion of the screw remains retained in the patient, it is made of a biocomposite material which is intended for implantation to allow for bone ingrowth.If the retained, it is unknown if the possible retained fragments will migrate and there is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.

• Brand Name: SCR BIORCI 7X30MM (7MM HEAD) STRL BX 1
• 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
• MDR Report Key: 14283594
• Report Number: 1219602-2022-00631
• Device Sequence Number: 1519695
• Product Code: HWC
• UDI-Device Identifier: 03596010426192
• UDI-Public: 03596010426192
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 10/01/2023
• Device Model Number: 7207555
• Device Catalogue Number: 7207555
• Device Lot Number: 50765096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown