MAUDE Adverse Event Report: STRYKER GMBH TITANIUM BONE SCREWS, CROSS-FIT, SELF-TAPPING, DIAM.2.3X22MM, (5/PCKG); PLATE, FIXATION, BONE

Model Number	52-23622S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "on (b)(6) 2021, the patient came to our hospital for internal fixation of the fracture due to the first metatarsal fracture of the left foot.After that, the patient recovered well.On (b)(6) 2022, the patient's x-ray reexamination showed that the screw was broken, and the patient had no obvious discomfort.On (b)(6) 2022, a surgery was performed to take the screw out, but the broken screw could not be removed and retained in the bone.".
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.Device remains implanted in the patient.
Additional Manufacturer Narrative
Correction: please refer to d1, d4 catalog number, gtin, g4 510k#.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information such as patient records as well as the affected device must be available to determine the root cause of the failure.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "on (b)(6)2021, the patient came to our hospital for internal fixation of the fracture due to the first metatarsal fracture of the left foot.After that, the patient recovered well.On (b)(6)2022, the patient's x-ray reexamination showed that the screw was broken, and the patient had no obvious discomfort.On (b)(6)-2022, a surgery was performed to take the screw out, but the broken screw could not be removed and retained in the bone.".

• Brand Name: TITANIUM BONE SCREWS, CROSS-FIT, SELF-TAPPING, DIAM.2.3X22MM, (5/PCKG)
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15965862
• Report Number: 0008031020-2022-00671
• Device Sequence Number: 5229695
• Product Code: HRS
• UDI-Device Identifier: 34546540244988
• UDI-Public: 34546540244988
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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
• Device Model Number: 52-23622S
• Device Catalogue Number: 59-23022
• Device Lot Number: 1000223308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• 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: Other
• Patient Sex: Unknown