MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX 2 ONE-THIRD TUBULAR 6 HOLE / L71MM; PLATE, FIXATION, BONE

Catalog Number	626676
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2025
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
It was reported that the plate broke without a fall or trauma described by the patient, which resulted in a revision surgery.
Event or Problem Description
It was reported that the plate broke without a fall or trauma described by the patient, which resulted in a revision surgery.
Additional Manufacturer Narrative
Please note the correction to h6 device code.The reported event could be confirmed, since the plate was returned broken.The device inspection revealed the following: the plate is broken apart at the level of the third hole.The scratches observed across the plate were most likely caused by the explantation of the device (not related to the breakage).The breakage surface resembles a fatigue fracture with uniform fine-grained texture over almost the complete surface and presence of rest lines.The shiny surfaces indicate the fragments rubbed against each other during the crack progress before the plate broke apart.Relevant dimensions were measured and showed the plate to be conforming to specifications.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.The broken plate was returned for evaluation and no product related issue could be detected.The evaluation of the device has shown that material fatigue due to high loads did lead to the breakage.However, the available information did not allow to determine the precise root cause of the breakage, as further documentation (such as x-rays or information related to post-operative activity) would have been necessary.If more information is provided, the case will be reassessed.

• Brand Name: ONE-THIRD TUBULAR PLATE VARIAX 2 ONE-THIRD TUBULAR 6 HOLE / L71MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22803494
• Report Number: 0008031020-2025-01366
• Device Sequence Number: 8960480
• Product Code: HRS
• UDI-Device Identifier: 07613327088724
• UDI-Public: (01)07613327088724(10)H60378
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151879
• 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): 11/12/2025

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: Lay User/Patient
• Device Catalogue Number: 626676
• Device Lot Number: H60378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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 Sex: Unknown