MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 10 HOLE / LEFT; PLATE, FIXATION, BONE

Catalog Number 628010

Device Problems Bent (1059); Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It is reported that on 8 feb, a patient received a variax clavicle plate, with a mid-shaft fracture.On (b)(6) on the control picture the plate seems to be bent.On (b)(6) the patient reports that there is a lumb and pain.The plate appears broken.On (b)(6) a recovery operation was done with an acumed plate (is thicker according to the doctor).The plate was intact at insertion.Is also not bent during ok and screws are placed according to procedure.

Manufacturer Narrative

The reported event that superior plate - decreased curvature variax clavicle 10 hole/left was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused by an overloading/precocious weightbearing on the implant.Indeed, the device inspection revealed the following: the clavicle plate is indeed broken in two pieces, at the level of the third circular hole on the medial side.The microscope inspection of the breakage surface show a shiny area, which proves that the two parts of the broken plate rubbed against each other for a while before the plate snapped completely (grey area corresponding to sudden fracture).Furthermore, on the shiny area, "beach marks" features can be noticed clearly.This behavior is usually caracteristic to fatigue fractures.As a reminder, the ifu clearly states: "post-operative patient activity: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation." 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 Description

It is reported that on (b)(6), a patient received a variax clavicle plate, with a mid-shaft fracture.On (b)(6) on the control picture the plate seems to be bent.On (b)(6) the patient reports that there is a lumb and pain.The plate appears broken.On (b)(6) a recovery operation was done with an acumed plate (is thicker according to the doctor) the plate was intact at insertion.Is also not bent during ok and screws are placed according to procedure.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 10 HOLE / LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7433420
• MDR Text Key: 105573099
• Report Number: 0008031020-2018-00297
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 628010
• Device Lot Number: L23482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR