MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 2.7MM / L24MM; PLATE, FIXATION, BONE

Model Number	614524
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "a 2.7 x 24mm locking screw (ref: 614524) of the elbow variax system was placed and at the moment when dr.Tightens it, the head is fractured leaving the rest of the screw inside the patient." procedure was completed successfully with no adverse consequences or surgical delay reported.
Event or Problem Description
As reported: "a 2.7 x 24mm locking screw (ref: 614524) of the elbow variax system was placed and at the moment when dr.Tightens it, the head is fractured leaving the rest of the screw inside the patient." procedure was completed successfully with no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
The reported could not be confirmed, since the device was not returned for evaluation and no other evidences were 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.H3 other text : device is not available for return, device is still implanted.

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 2.7MM / L24MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9419492
• Report Number: 0008031020-2019-02034
• Device Sequence Number: 19250442
• Product Code: HRS
• UDI-Device Identifier: 07613154969548
• UDI-Public: 07613154969548
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K101056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: Health Professional
• Device Model Number: 614524
• Device Catalogue Number: 614524
• Device Lot Number: X16017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1