MAUDE Adverse Event Report: STRYKER GMBH TITANIUM BONE SCREWS, CROSS-FIT, SELF-TAPPING, DIAM.2.3X12MM, (5/PCKG); PLATE, FIXATION, BONE

Model Number	59-23012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided despite multiple attempts.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition unknown.
Event or Problem Description
As reported: "on (b)(6) 2018 fix two metabolic fractures using two profile combo 2.3mm screws.(no plate used, two screws inserted alone).Withdrawal operation after healing on (b)(6) 2020 makes removal difficult.When i tried to remove the screw with the removal screwdriver, both heads were immediately broken.Withdrawal became difficult, and the operation was once completed.On the same day, the dealer brought in synthes' broken screw removal instrument and re-operated to remove all implants.".

• Brand Name: TITANIUM BONE SCREWS, CROSS-FIT, SELF-TAPPING, DIAM.2.3X12MM, (5/PCKG)
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9772363
• Report Number: 0008031020-2020-00533
• Device Sequence Number: 2891193
• Product Code: HRS
• UDI-Device Identifier: 34546540244889
• UDI-Public: 34546540244889
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: Health Professional
• Device Model Number: 59-23012
• Device Catalogue Number: 59-23012
• Device Lot Number: 1000315951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention