MAUDE Adverse Event Report: STRYKER GMBH DISTAL MEDIAL HUMERUS PLATE VARIAX ELBOW LEFT / RIGHT HUMERUS 6 HOLE / L116MM; PLATE, FIXATION, BONE

Model Number	629386S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Despite the lack of evidence, the description of the reported event indicates that the root cause can be attributed to an user related issue.The implantation of a non-sterile device should be strictly avoided due to risks of infection.As a reminder, the instructions for use clearly state that: " in the event of contamination, or expiration of shelf life or in the case of products supplied non-sterile, the product must be subjected to an appropriate cleaning process and sterilized by means of a validated sterilization procedure before use, unless specified otherwise in the product labeling or respective product technical guides.Products which have already been used in a surgically invasive manner, even if implanted only partly or temporarily during the surgical procedure, must not be reprocessed for reuse.".Medical experts have also stated that: ¿in case of the expiration of shelf-life stryker cannot guarantee the performance and safety for use.Re-sterilization is only possible for those devices where stryker explicitly describes a re-sterilization process it in the ifu.The risk of infection will increase with the time passed after the expiry date which is printed on the packaging.¿.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: device remains implanted.
Event or Problem Description
It was reported that an out of date implant was used in a patient.

• Brand Name: DISTAL MEDIAL HUMERUS PLATE VARIAX ELBOW LEFT / RIGHT HUMERUS 6 HOLE / L116MM
• 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: 17159555
• Report Number: 0008031020-2023-00238
• Device Sequence Number: 15220196
• Product Code: HRS
• UDI-Device Identifier: 04546540598097
• UDI-Public: 04546540598097
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2023

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 Expiration Date: 02/28/2023
• Device Model Number: 629386S
• Device Catalogue Number: 629386S
• Device Lot Number: Y10725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• 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
• Patient Sex: Female