MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM; ROD, FIIXATION, INTRAMEDULLARY AND ACCESORIES

Model Number	1896-5050S
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.The device disposition is unknown.
Event or Problem Description
It was reported that there was a failure with the t2 femur screw 5,5mm.The screw didn't rotate in the nail.
Event or Problem Description
It was reported that there was a failure with the t2 femur screw 5,5mm.The screw didn't rotate in the nail.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned, and no additional information was available.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.No indications of material, manufacturing or design related problems were found during the investigation.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.If any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Please note the corrections made to the h6 device code and the manufacturer entity: the reported event was not confirmed, since the device was not returned, and no additional information was available.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.No indications of material, manufacturing or design related problems were found during the investigation.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.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that there was a failure with the t2 femur screw 5,5mm.The screw didn't rotate in the nail.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM
• Common Device Name: ROD, FIIXATION, INTRAMEDULLARY AND ACCESORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15255177
• Report Number: 0009610622-2022-00381
• Device Sequence Number: 6636026
• Product Code: HSB
• UDI-Device Identifier: 04546540202512
• UDI-Public: 04546540202512
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2023

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: 02/28/2026
• Device Model Number: 1896-5050S
• Device Catalogue Number: 18965050S
• Device Lot Number: K0F337E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 09/28/2023
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/26/2022; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown