MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 7X25 7MM HEAD STERILE; SCREW, FIXATION, BONE

Model Number	7207674
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an aclr procedure, the biorci screw broke while inserting into the bone.All the broken pieces were retrieved from the patient with suction.The procedure was completed without surgical delay using a back-up device in the originally drilled bone hole.No further complications were reported.The patient was discharged from the hospital.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6:a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the raw material 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.A clinical review states as of the date of this medical investigation, the requested clinical documentation including the surgical report has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.No patient harm as been alleged.Therefore, no further clinical/medical assessment is warranted at this time.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: SCR BIORCI-HA 7X25 7MM HEAD 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: 15860793
• Report Number: 1219602-2022-01813
• Device Sequence Number: 20332005
• Product Code: HWC
• UDI-Device Identifier: 03596010459916
• UDI-Public: 03596010459916
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 07/20/2026
• Device Model Number: 7207674
• Device Catalogue Number: 7207674
• Device Lot Number: 50954588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 11/24/2022
• Supplement Report FDA Received Date: 01/12/2023
• Date Device Manufactured: 07/20/2021
• 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