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	No Information (3190)
Date of Event	07/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an acl reconstruction, while tightening the biorci-ha screw in the tibia, it broke.All pieces were removed from the patient.The procedure was completed without significant delay using a back-up device in the same bone hole.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 10mmx30mm 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 without the return of the device; however, factors that could have contributed to the reported event include: not preparing the insertion site with the proper starter or tap.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.

• 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: 10369201
• Report Number: 1219602-2020-01176
• Device Sequence Number: 3463718
• 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
• Report Date (Section B): 09/03/2020

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?: No
• Initial Date Received by Manufacturer: 07/12/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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: Required Intervention