MAUDE Adverse Event Report: STRYKER GMBH DISTAL MEDIAL HUMERUS PLATE - EXTENDED VARIAX ELBOW LEFT / RIGHT HUMERUS 4 HO; PLATE, FIXATION, BONE

Catalog Number	629284
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported the following: "i have been informed of an incident that occurred during the installation of a variax plate ref.(b)(4): a fragment of plate detached itself in the form of a thread during screwing, causing a wound on the surgeon's right hand.An accident due to exposure to blood and a work-related accident were reported.".
Additional Manufacturer Narrative
Corrections: please refer to section d9 the device was not returned.The plate was not returned for evaluation as it has been according to the received information properly implanted.The reported event that a fragment of plate detached could not be confirmed because the evaluation of the received picture and of the returned screw has shown that the reported fragment came from the screw and not from the plate.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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported the following: "i have been informed of an incident that occurred during the installation of a variax plate ref.629284: a fragment of plate detached itself in the form of a thread during screwing, causing a wound on the surgeon's right hand.An accident due to exposure to blood and a work-related accident were reported.".

• Brand Name: DISTAL MEDIAL HUMERUS PLATE - EXTENDED VARIAX ELBOW LEFT / RIGHT HUMERUS 4 HO
• 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: 19792458
• Report Number: 0008031020-2024-00272
• Device Sequence Number: 17914488
• Product Code: HRS
• UDI-Device Identifier: 07613154970629
• UDI-Public: 07613154970629
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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 Catalogue Number: 629284
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown