MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 3.5MM / L14MM; PLATE, FIXATION, BONE

Catalog Number	614614
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed only by consulting the provided x-rays.Based on investigation, the root cause was attributed to be user / patient related.The failure was caused by insufficient reduction of the fracture (no ulnar plate).Original statement from our medical expert: "from the first x-ray it was clear that there might be an upcoming problem with pseudarthrosis which was developed then in the end.The patient had a supracondylar fracture of the humerus, which was treated with a radial plate only.The restoration and reposition of the fragments is poor from the beginning but this is pretty hard to assess with only ap-views.However, in the first x-ray you can see that there is a clear incongruity of the fragments (condensed zone radially, completely irregular shape of the olecranal fossa of the humerus and some malalignment of the ulnar cortex).The surgeon decided not to put a plate on the ulnar aspect of the fracture (it is possible to treat this kind of fracture only with a radial plate, but it is not recommendable, especially if, like in this case, the reduction of the fragment is poor).As a result non-union and pseudarthrosis and, in the end, complete loosening of the plate occurs.This is clearly a surgical issue with two main aspects: no sufficient reduction of the fracture and no ulnar plate.This has nothing to do with the plate or screws of the manufacturer and is not device related." 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
When following up after surgery, the screw at the distal part was detached from the screw.It was pseudoarthrotic and about 2 years after surgical procedure.Based on x ray image, the screw head slipped through the plate.Operation scheduled for removal on (b)(6).

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 3.5MM / L14MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9120738
• Report Number: 0008031020-2019-01327
• Device Sequence Number: 19540750
• Product Code: HRS
• UDI-Device Identifier: 07613154969753
• UDI-Public: 07613154969753
• Combination Product (Y/N): N
• PMA/510(K) Number: K101056
• 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
• Report Date (Section B): 09/25/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 614614
• Device Lot Number: V50480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/25/2019
• 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: 72