MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 10X30 STERILE; SCREW, FIXATION, BONE

Model Number	7209017
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while inserting the screw in tibia, it suddenly broke.There was a delay shorter than 30 minutes and the problem was solved using a back up device and removing the pieces with a curette and forceps.No additional bone holes were required patient harm.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h6: the reported 10x30mm biorci ha screw, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the screw broke during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not using the appropriate starter or tap prior to insertion.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device tip had fractured off.There was significant deformation around the fracture and some deformation on the distal threads.Some debris was present between the threads.Based on the condition of the product material found during visual inspection it was determined that additional material testing is not required.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.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 review of the polymer found that the storage protocols, material specifications, and material tests were appropriately documented.A clinical investigation concluded that the procedure change did not result in a significant delay or patient injury/impact.Per subsequent e-mail, the pieces of the broken screw were removed with a curettage and forceps.There was no patient harm reported or additional bone holes required; therefore, no further clinical assessment is warranted at this time.The complaint was confirmed.Factors that could have contributed to the reported event include off-axis insertion, excessive force or bending during use, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

• Brand Name: SCR BIORCI-HA 10X30 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10242738
• Report Number: 1219602-2020-00973
• Device Sequence Number: 19454213
• Product Code: HWC
• UDI-Device Identifier: 03596010460042
• UDI-Public: 03596010460042
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2021

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: 09/25/2024
• Device Model Number: 7209017
• Device Catalogue Number: 7209017
• Device Lot Number: 50830202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 08/11/2020; 04/30/2021
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/12/2020; 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention