MAUDE Adverse Event Report: STRYKER GMBH DISTAL MEDIAL HUMERUS PLATE VARIAX ELBOW LEFT / RIGHT HUMERUS 3 HOLE / L67MM; PLATE, FIXATION, BONE

Model Number	629383S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient complains of pain and bone fusion failure and screw backout were found.It was determined that there was no infection, but there was a suspicion of metal allergy.".
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.
Event or Problem Description
As reported: "patient complains of pain and bone fusion failure and screw backout were found.It was determined that there was no infection, but there was a suspicion of metal allergy.".
Additional Manufacturer Narrative
The reported event could be confirmed, since an x-ray was provided which matches the alleged failure mode.The device inspection was not possible as the product was not returned 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.An x-ray was provided which was presented to our health care professional for evaluation, and a question about the most likely reason for the screw backout was asked, to which the medical expert replied: ¿with the limited information available it is almost impossible to give a root cause.The first cause could be improper locking of the locking screws, or improper use of the locking screws (outside of the cone/ angle in which the screws can be properly locked.Second could be related to the construction being unstable, which may have caused too much movement of the parts, which lead to screw movement and loosening.However as said, based on the available information an actual cause cannot be determined.¿ 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.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: DISTAL MEDIAL HUMERUS PLATE VARIAX ELBOW LEFT / RIGHT HUMERUS 3 HOLE / L67MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16189653
• Report Number: 0008031020-2023-00024
• Device Sequence Number: 5807602
• Product Code: HRS
• UDI-Device Identifier: 07613327082432
• UDI-Public: 07613327082432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 629383S
• Device Catalogue Number: 629383S
• Device Lot Number: H56713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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 Age: 74 YR
• Patient Sex: Male