MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 7X25 8MM HEAD STERILE; SCREW, FIXATION, BONE

Model Number	7207675
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery the biorci was found to be broken when it was being inserted into the patient's body.Surgery was completed using a smith and nephew back up device with no significant delay.
Event or Problem Description
It was reported that during an acl surgery the biorci was found to be broken when it was being inserted into the patient's body.All the broken pieces were removed using tweezers.Surgery was completed using a smith and nephew back up device with no significant delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported screw biorci-ha 7x25 w/8mm head, 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 recommended prep device prior to insertion of the screw.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 7X25 8MM HEAD STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10293080
• Report Number: 1219602-2020-01082
• Device Sequence Number: 923233
• Product Code: HWC
• UDI-Device Identifier: 03596010459930
• UDI-Public: 03596010459930
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2020

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: 10/04/2023
• Device Model Number: 7207675
• Device Catalogue Number: 7207675
• Device Lot Number: 50762647
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/06/2020; 08/14/2020
• Initial Report FDA Received Date: 07/18/2020
• Supplement Report FDA Received Date: 07/23/2020; 08/18/2020
• Patient Sequence Number: 1