MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 Ø5X35 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965035S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
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 disposition is unknown.
Event or Problem Description
As reported: "distal screw breakage.The surgery was performed for reasons not due to the rupture of the screw and it still had to be done.The operative time extension had no consequences for the patient." 4/23/2024 - update: the clinician also states that the operation on (b)(6) 2024 was performed for reasons not due to the breakage of the screw (removal of tibial nail) and that the breakage of the screw only caused an extension of the surgical times (as the broken screw caused difficulties in removal).
Event or Problem Description
As reported: "distal screw breakage.The surgery was performed for reasons not due to the rupture of the screw and it still had to be done.The operative time extension had no consequences for the patient." on 4/23/2024 - update the clinician also states that the operation of (b)(6) 2024 was performed for reasons not due to the breakage of the screw (removal of tibial nail) and that the breakage of the screw only caused an extension of the surgical times (as the broken screw caused difficulties in removal).
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 Ø5X35 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: 19226424
• Report Number: 0009610622-2024-00181
• Device Sequence Number: 8361234
• Product Code: HSB
• UDI-Device Identifier: 04546540202482
• UDI-Public: 04546540202482
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 18965035S
• Device Lot Number: K06213D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Unknown