MAUDE Adverse Event Report: STRYKER GMBH HOOK PLATE VARIAX CLAVICLE 5 HOLE / 16MM / LEFT; PLATE, FIXATION, BONE

Model Number	628525S
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted.
Event or Problem Description
It was reported: during variax clavicle surgery, the locking screw did not lock to the second hole from the distal of the plate.The surgeon exchanged the screw to the new one, but the situation was not changed.The surgeon inserted the second screw as it is to the hole and finished the surgery.The screw is available and will be returned first.Few months later, the plate will be returned after the extraction.
Additional Manufacturer Narrative
The reported event could not be confirmed.According to the variax 2 clavicle operative technique guide ¿only non-locking screws may be placed in the oblong holes of the plate.Circular holes accept either locking or non-locking screws.¿ 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.According to the initial event description, ¿the locking screw did not lock to the second hole from the distal of the plate.¿ the reported plate is hook plate variax clavicle 5 hole / 16mm / left and the 2nd hole from the distal of the plate is an oblong hole.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported: during variax clavicle surgery, the locking screw did not lock to the second hole from the distal of the plate.The surgeon exchanged the screw to the new one, but the situation was not changed.The surgeon inserted the second screw as it is to the hole and finished the surgery.The screw is available and will be returned first.Few months later, the plate will be returned after the extraction.

• Brand Name: HOOK PLATE VARIAX CLAVICLE 5 HOLE / 16MM / LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9387600
• Report Number: 0008031020-2019-01992
• Device Sequence Number: 2242739
• Product Code: HRS
• UDI-Device Identifier: 07613327085426
• UDI-Public: 07613327085426
• Combination Product (Y/N): N
• PMA/510(K) Number: K140259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 628525S
• Device Catalogue Number: 628525S
• Device Lot Number: Y46879
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1