MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN LOCKING SCREW; IMPLANT

Model Number	40-15081S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
The end user has reported that: variax2 foot plate turns out be broken at screw-plate interface during material 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.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.
Event or Problem Description
The end user has reported that: variax2 foot plate turns out be broken at screw-plate interface during material removal.
Additional Manufacturer Narrative
Corrections of the primary device, d1, d2a, d2b, d4 catalog, lot & gtin number, h4, h6 method code.The reported event could be confirmed, only based on the x-rays received.The x-rays showed that one of the screws is broken at its lower part.Even though the x-rays were returned, a root-cause could not be established as the operative reports are needed to understand the surgeon's choice for a long screw at this position.Therefore, 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 was not possible because the lot number was not communicated.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.
Event or Problem Description
The end user has reported that: variax2 foot plate turns out be broken at screw-plate interface during material removal.Additional information: from the provided x-ray, we can actually see a broken screw.The plate looks intact, and the event is most likely related to this screw.

• Brand Name: UNKNOWN LOCKING SCREW
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10285841
• Report Number: 0008031020-2020-01918
• Device Sequence Number: 10891431
• Product Code: HRS
• UDI-Device Identifier: 04546540538727
• UDI-Public: 04546540538727
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2021

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: Lay User/Patient
• Device Model Number: 40-15081S
• Device Catalogue Number: 40-15081S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 01/19/2021
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/06/2020; 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1