MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 8X25 STERILE; SCREW, FIXATION, BONE

Catalog Number	7207678
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction surgery, the biorci screw broke.The procedure was successfully completed using a smith and nephew back up device.There was a 1-30 min delay.All the pieces were removed using suction.There was no void left in the patient.No further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information on b5 and h6.
Event or Problem Description
It was reported that during an acl reconstruction surgery, the biorci screw broke.The procedure was successfully completed using a smith and nephew back up device.It is unknown if there was a surgical delay.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H10: h2: additional information: b5.
Event or Problem Description
It was reported that during an acl reconstruction surgery, the biorci screw broke.The procedure was successfully completed using a smith and nephew back up device.There was a 1-30 min delay.All the pieces were removed using suction.There was no void left in the patient.The back up device was used in the original drilled bone hole.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was returned in original packaging with the batch number of the complaint on the label.The screw is fractured at the distal tip.The fractured piece was not returned.Bio debris is present.Based on the condition of the product material found during visual inspection, additional material testing is not required.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 complaint history review found similar reported events.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 anchor material specification, 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.The root cause was associated with unintended use of the device.Factors that could have contributed to the failure 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.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: SCR BIORCI-HA 8X25 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: 21357888
• Report Number: 1219602-2025-00350
• Device Sequence Number: 12908948
• Product Code: HWC
• UDI-Device Identifier: 03596010459961
• UDI-Public: 3596010459961
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/12/2025

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: 01/28/2026
• Device Catalogue Number: 7207678
• Device Lot Number: 50918721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/09/2025; 02/13/2025; 03/11/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 02/13/2025; 02/24/2025; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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
• Patient Sex: Unknown