MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW IMN SCREWS Ø5X35MM; SCREW, FIXATION, BONE

Catalog Number	23605035S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/04/2024
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 discarded by user.
Event or Problem Description
As reported: "orif was performed for femoral condyle fracture on (b)(6) 2024.However, it was found that fixation was not achieved on (b)(6) 2024.Thus, revision surgery to remove the devices was performed on (b)(6) 2024.The doctor told that the original fracture was severe, and although the devices were implanted in hopes of reducing and maintaining the fracture, the fracture part remained unstable after surgery.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was 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.In the case presented an unknown patient was treated with above advanced locking screw on (b)(6) 2024.Orif was performed for femoral condyle fracture.On (b)(6) 2024, the implant was removed because intended fixation had not been achieved on (b)(6) 2024.A revision implant was not identified.On request we received a surgeon¿s explanation that the original fracture was severe, and although the devices were implanted in hopes of reducing and maintaining the fracture, the fracture part remained unstable after surgery.Medical records were not provided due to hospital policy.If the device is returned or if any additional information is provided, the investigation will be reassessed.With available information a real root cause could not be determined.According to received information the patient¿s condition contributed to the event.With available information a product deficiency was not verified.
Event or Problem Description
As reported: "orif was performed for femoral condyle fracture on (b)(6) 2024.However, it was found that fixation was not achieved on (b)(6) 2024.Thus, revision surgery to remove the devices was performed on (b)(6) 2024.The doctor told that the original fracture was severe, and although the devices were implanted in hopes of reducing and maintaining the fracture, the fracture part remained unstable after surgery.".

• Brand Name: LOCKING SCREW IMN SCREWS Ø5X35MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 19027915
• Report Number: 0009610622-2024-00122
• Device Sequence Number: 17888890
• Product Code: HWC
• UDI-Device Identifier: 07613327366198
• UDI-Public: 07613327366198
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23605035S
• Device Lot Number: K127BBE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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 Sex: Unknown