MAUDE Adverse Event Report: STRYKER GMBH VARIAX 2 ONE-THIRD ONE-THIRD TUBULAR PLATE 8 HOLE / L95MM; PLATE, FIXATION, BONE

Catalog Number	626678
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the surgeon had to reopen one of his patients because the plate placed on (b)(6) 2024 was broken.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the surgeon had to reopen one of his patients because the plate placed on (b)(6) 2024 was broken.".
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could be confirmed since the device was not returned for evaluation but with available radiograph breakage could be confirmed.With the available radiograph formal medical opinion was sought: plate breakage after clavicle orif typically reflects an interplay of biological (e.G., nonunion), mechanical (e.G., overload), and technical (e.G., plate choice or positioning) factors.But with no provided information about mechanical overload (early return to activity or noncompliance with post-operative restrictions that can lead to stresses exceeding the plate¿s fatigue strength, nor information about heavy lifting, falls, or trauma during healing).We are also missing information on the fracture reduction and stability of the fixation intraoperative, and on the presence of a delayed union with or without infection postoperatively, with these missing information root cause could not be determined.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.
Additional Manufacturer Narrative
Corrections: please refer to sections d9 the device was returned and h6 (method and results codes).The reported event could be confirmed since the device was returned for evaluation, and matches alleged event as visible in the available radiograph.The returned device underwent visual inspection and was found to have fractured into two separate fragments originating near the fourth locking hole from the identification-marking side.Microscopic examination showed a mixed fracture pattern, with visible arrest lines indicating fatigue progression and a shiny, smooth area at the fracture end consistent with brittle failure.The polished surfaces of the fragments suggest repeated rubbing during service, followed by a final sudden overload that caused the brittle break.With the available radiograph formal medical opinion was sought: plate breakage after clavicle orif typically reflects an interplay of biological (e.G., nonunion), mechanical (e.G., overload), and technical (e.G., plate choice or positioning) factors.But with no provided information about mechanical overload (early return to activity or noncompliance with post-operative restrictions that can lead to stresses exceeding the plate¿s fatigue strength, nor information about heavy lifting, falls, or trauma during healing).We are also missing information on the fracture reduction and stability of the fixation intraoperative, and on the presence of a delayed union with or without infection postoperatively, with these missing information root cause could not be determined.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.No product related issue could be detected during the performed investigation of the returned device.The implant ultimately failed to withstand the applied force, resulting in material overload and fatigue failure.Based on the limited information available, the root cause of the reported event cannot be defined as this is often muti-factorial: the location of the fracture and the technical aspects of the surgical procedure could have contributed to the event.Furthermore, patient condition and activity levels post-op may also have contributed to an inadequate load distribution, and therefore the breakage of the implant.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the surgeon had to reopen one of his patients because the plate placed on (b)(6) 2024 was broken.".

• Brand Name: VARIAX 2 ONE-THIRD ONE-THIRD TUBULAR PLATE 8 HOLE / L95MM
• 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: 21713264
• Report Number: 0008031020-2025-00447
• Device Sequence Number: 10010286
• Product Code: HRS
• UDI-Device Identifier: 07613327088823
• UDI-Public: (01)07613327088823(10)AB2156
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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: 626678
• Device Lot Number: AB2156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 05/09/2025; 03/10/2026
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/05/2025; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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