MAUDE Adverse Event Report: STRYKER GMBH HOOK PLATE VARIAX CLAVICLE 6 HOLE / 12MM / RIGHT; PLATE, FIXATION, BONE

Catalog Number	628516S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Erythema (1840); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "stimulation of soft tissue due to locking screw backout.The locking screw was removed." 09/06/2025 - additional information received: "the screw at the most distal end of the hook plate was also loose, but that was completely locked when it was re-tightened, so it was re-tightened.The backed-out screw caused irritation, and the skin on the clavicle surface was red and swollen.".
Event or Problem Description
As reported: "stimulation of soft tissue due to locking screw backout.The locking screw was removed." 09/06/2025 - additional information received: "the screw at the most distal end of the hook plate was also loose, but that was completely locked when it was re-tightened, so it was re-tightened.The backed-out screw caused irritation, and the skin on the clavicle surface was red and swollen.".
Additional Manufacturer Narrative
A device inspection was not possible since the affected device was not returned.A post-operative x-ray picture was received.It could be confirmed that the plate has dislocated and that two screws have backed out.Despite confirming the event, it was not possible to determine the exact root cause.In addition to the return of the devices, more information such as patient medical records and patient post-operative behavior as well as more x-ray images, would have been required for a complete investigation.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.

• Brand Name: HOOK PLATE VARIAX CLAVICLE 6 HOLE / 12MM / RIGHT
• 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: 23184987
• Report Number: 0008031020-2025-01650
• Device Sequence Number: 9182522
• Product Code: HRS
• UDI-Device Identifier: 07613327085525
• UDI-Public: (01)07613327085525(17)280831(10)AD4695
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 628516S
• Device Lot Number: AD4695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2023
• 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 Age: 60 YR
• Patient Sex: Male