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

Catalog Number	7207675
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cl reconstruction surgery the screw fractured when screw in, all pieces were removed and no additional bone holes were performed.The procedure was successfully completed with a backup device, no significant delay reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: two 7207675 scr biorci-ha 7x25 8mm head sterile intended for use in treatment have been returned for evaluation.The information provided states: ¿during a cl reconstruction surgery two screws were fractured when screw in, all pieces were removed and no additional bone holes was performed¿.Visual assessment confirms the complaint.The screws were returned fractured.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during insertion.Improper site preparation.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of the complaint and manufacturing records was performed and indicated similar allegations for the lot number reported.

• 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: 10125335
• Report Number: 1219602-2020-00851
• Device Sequence Number: 2392610
• Product Code: HWC
• UDI-Device Identifier: 03596010459930
• UDI-Public: 3596010459930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002274
• 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
• Report Date (Section B): 07/30/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2022
• Device Catalogue Number: 7207675
• Device Lot Number: 50691797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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: Other
• Patient Weight: 72