MAUDE Adverse Event Report: STRYKER GMBH VARIAX CLAVICLE SUPERIOR PLATE - DECREASED CURVATURE 8 HOLE / LEFT; PLATE, FIXATION, BONE

Catalog Number	628008S
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon gave permission to move, but carrying heavy objects was prohibited.The bone had not healed, and the patient did not follow the postoperative instructions given by the physician and carried heavy objects.Subsequently, the patient developed pain, and it was found that the distal screw had disengaged.Non-union was noticed.The following screws were reported: 628008s-an0945, 657314s-ap4098, 657316s-ak1949, 657316s-al5041, 657322s-ae2045, 657414s-an4264, 657416s-ap4102, and 657418s-al1388.It was reported that they were unable to determine which screw was loose.However, it was reportedly the distal screw, although it is unknown which specific screw.As a result, a revision procedure was performed to replace the plate and the screws.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The surgeon gave permission to move, but carrying heavy objects was prohibited.The bone had not healed, and the patient did not follow the postoperative instructions given by the physician and carried heavy objects.Subsequently, the patient developed pain, and it was found that the distal screw had disengaged.Non-union was noticed.The following screws were reported: (b)(6).It was reported that they were unable to determine which screw was loose.However, it was reportedly the distal screw, although it is unknown which specific screw.As a result, a revision procedure was performed to replace the plate and the screws.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.It must be noted that it has been reported that the patient failed to follow the postoperative instructions given by the surgeon.This is a potential cause of the alleged bone non-union and screw loosening.However, without more information and x-ray images, the corrolation betweeen the patient's behavior and the reported event could not be confirmed.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 more information is provided, the case will be reassessed.

• Brand Name: VARIAX CLAVICLE SUPERIOR PLATE - DECREASED CURVATURE 8 HOLE / LEFT
• 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: 24710461
• Report Number: 0008031020-2026-00477
• Device Sequence Number: 5777686
• Product Code: HRS
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 628008S
• Device Lot Number: AN0945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• 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: 61 YR
• Patient Sex: Male