MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X30 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965030S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "35 mm was planed to insert, but 30mm screw was incorrectly opened and inserted.It was confirmed that the tip of the screw penetrated the cortex.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains in patient body.
Additional Manufacturer Narrative
Please note correction to section h6 method code.The reported event could not be confirmed, since no evidence was provided for evaluation.A device inspection was not possible since the device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Although the issue could not be confirmed due to lack of evidence but since the reported issue is clearly a user related event, the root cause of the issue can be deemed as user related.Through the additional information it was communicated by the user that they accepted that the issue was due to a fault of their own in selecting the implant and no other action is required.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "35 mm was planed to insert, but 30mm screw was incorrectly opened and inserted.It was confirmed that the tip of the screw penetrated the cortex.".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X30 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 18034812
• Report Number: 0009610622-2023-00378
• Device Sequence Number: 7419751
• Product Code: HSB
• UDI-Device Identifier: 04546540202468
• UDI-Public: 04546540202468
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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: 04/30/2026
• Device Catalogue Number: 18965030S
• Device Lot Number: K048462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian