MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5040S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains in the patient.
Event or Problem Description
As reported: "surgeon inserted a 5.0 locking screw acting as a "blocking screw." while inserting the scn (supracondylar nailing system), the nail broke the blocking screw in half.The surgeon was able to remove the top half of the screw, but the bottom half was left in the patient permanently.The scn was implanted and the rest of the case was completed successfully.".
Additional Manufacturer Narrative
Correction: refer to h3 (reason code); h6 conclusion code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the received information it¿s clear that locking screw was inserted prior to the scn nail to guide the nail as a blocking technique which is not specified in the respective operative technique of scn nailing system.Hence, it can be concluded that the event is user related (off label use).If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device is not available; disposed by hospital.
Event or Problem Description
As reported: "surgeon inserted a 5.0 locking screw acting as a "blocking screw." while inserting the scn (supracondylar nailing system), the nail broke the blocking screw in half.The surgeon was able to remove the top half of the screw, but the bottom half was left in the patient permanently.The scn was implanted and the rest of the case was completed successfully.".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11237993
• Report Number: 0009610622-2021-00252
• Device Sequence Number: 19654018
• Product Code: HSB
• UDI-Device Identifier: 04546540202499
• UDI-Public: 04546540202499
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 07/31/2025
• Device Model Number: 1896-5040S
• Device Catalogue Number: 18965040S
• Device Lot Number: K03BB0D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR