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

Catalog Number	628008S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Postoperative, implanted screw was backout.As primary procedure, implanted the first 8 hole superior row bend plate, but replaces using superior low bend 10 holes as revision surgery.
Additional Manufacturer Narrative
The reported event that superior plate - decreased curvature variax clavicle 8 hole / left was alleged of 'migration / rotation / in situ movement' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by putting locking screws into oblong holes.Indeed, the device inspection revealed the following: the plate and screws do not present any significant signs of wear or scratches.They are all in general in a good state.However it is crucial to know that the plate returned contains 4 universal holes, and 4 oblong holes, and 6 locking screws were returned.When the oblong holes are inspected more thoroughly, it can be noticed that two of them show traces of metal deformation, proving that the extra two locking screws were installed there.This is in violation of the operative technique indications.Indeed, it is clearly stated in the operative technique.Only non-locking screws may be placed in the oblong holes of the plate.Circular holes accept either locking or non-locking screws.The returned locking screws all lock perfectly to the plate when put in the universal holes.As a final note, all the tested screws are perfectly functional in the oblong holes.No matter which ones of the reported screws were implanted in the oblong holes, their general functionality is perfectly given.The reason of the back out is the aforementioned deviation from the surgical technique 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 investigation report will be updated.
Event or Problem Description
Postoperative, implanted screw was backout.As primary procedure, implanted the first 8 hole superior row bend plate, but replaces using superior low bend 10 holes as revision surgery.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 8 HOLE / LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8126112
• Report Number: 0008031020-2018-01024
• Device Sequence Number: 2363654
• Product Code: HRS
• UDI-Device Identifier: 04546540686879
• UDI-Public: 04546540686879
• Combination Product (Y/N): N
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 628008S
• Device Lot Number: Y02180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR