MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 9X25 STERILE; SCREW, FIXATION, BONE

Model Number	7207681
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during an acl reconstruction, the biorci screw broke during insertion into tibia.All the broken pieces were retrieved using tweezers and no additional bone hole was required.The procedure was completed with a backup device and no significant delay was reported.No further complications were reported.
Additional Manufacturer Narrative
H10 h6 the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A complaint history review concluded this was a repeat issue.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 review of risk management files found that the reported failure was documented appropriately.A review of raw materials found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A review of customer provided image found a screw fractured into multiple pieces.One undated photo was provided for review and confirms the reported screw breakage.Per e-mail communication the broken pieces where retrieved from the patient.The procedure was completed using a back-up device.It was also communicated that the ¿patient is fine.¿ since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed.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, 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.

• Brand Name: SCR BIORCI-HA 9X25 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12322443
• Report Number: 1219602-2021-01721
• Device Sequence Number: 4508343
• Product Code: HWC
• UDI-Device Identifier: 03596010460004
• UDI-Public: 03596010460004
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: 09/14/2025
• Device Model Number: 7207681
• Device Catalogue Number: 7207681
• Device Lot Number: 50895521
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 08/15/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR