MAUDE Adverse Event Report: STRYKER GMBH CURVED PLATE, 4 HOLES; PLATE, FIXATION, BONE

Model Number	40-15011
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the variax 2 locking screws t10 2.7 have not locked in the plate.Replacement was available." additional information: the first look here should be on the plate, the doctor told me.The screw seems to be "welded¿ with the plate.I have no numbers for the screw but they are both on the post way to stryker for evaluation.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the reported event.The visual & functional inspections show that the screw turns into the plate hole without being able to lock and without the possibility to be extracted.The titanium locking lips show some slight deformation, showing that screws were inserted into them.A close up on the bottom of the screw head shows that the thread of the locking mechanism was partially torn up.This could explain the impossibility stop the screw from spinning, as well as the difficulty extracting the screw from the plate.Since the plate's screw holes were already used, a dimensional inspection on the returned device could not be trusted.Therefore, a dimensional inspection on a new plate from the same lot number was performed.A new piece was taken out of stock to check that the screw holes have been manufactured according to specifications.The dimensional inspection of all four holes shows that they were, with a diameter of 2.85mm.Based on investigation, the root cause of the event was not attributed to the plate.An nc was opened to investigate the screw further.Please refer to complaint (b)(4) for more details.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 any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "the variax 2 locking screws t10 2.7 have not locked in the plate.Replacement was available." additional information: the first look here should be on the plate, the doctor told me.The screw seems to be ¿welded¿ with the plate.I have no numbers for the screw but they are both on the post way to stryker for evaluation.

• Brand Name: CURVED PLATE, 4 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11333314
• Report Number: 0008031020-2021-00041
• Device Sequence Number: 16349524
• Product Code: HRS
• UDI-Device Identifier: 07613154627783
• UDI-Public: 07613154627783
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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 Model Number: 40-15011
• Device Catalogue Number: 40-15011
• Device Lot Number: 1000412188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1