MAUDE Adverse Event Report: STRYKER GMBH ANTERIOR MIDSHAFT PLATE VARIAX CLAVICLE 10 HOLE; PLATE, FIXATION, BONE

Catalog Number	628310
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/31/2018
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
Plate broke 10 weeksafter implantation.Patient was stretching and felt a pop.Went in for x-rays and plate was broke.Revision of a broken clavicle plate with dr.(b)(6).
Event or Problem Description
Plate broke 10 weeks after implantation.Patient was stretching and felt a pop.Went in for x-rays and plate was broke.Revision of a broken clavicle plate with dr.(b)(6).
Additional Manufacturer Narrative
Corrections to cat number.The reported event that anterior midshaft plate variax clavicle 10 hole 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 weight bearing on the implant on extended periods of time.The device inspection revealed the following: the clavicle plate that was returned was confirmed to be broken at the level of the 4th hole from the medial side of the plate.A microscope analysis of the surface breakages shows that the material of one of the two bridges is shiny, which proves that the device most likely broke at that level first.That first breakage was most probably due to an important and repetitive patient activity ( overloading, precocious weight bearing, high activity level of the patient.).After the first bridge breakage, the two sides of the plate rubbed against each other for some cycles before the second bridge broke too.The surface of the second bridge shows a matte grain of the material, which proves that the material broke at once (sudden fracture of the material), again as a result of too high of a force applied of the material.The behavior previously is usually characteristic to a fatigue fracture of the implant.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.[.]".The surface material of the second bridge of the device shows a small dot, which corresponds to the starting point of the laser welding of the smart titanium lip that allows the locking screws to lock on the plate.Breakage of the plate is not connected with it since the starting point of the fracture is not located on the smart lip, and not on that bridge either.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.

• Brand Name: ANTERIOR MIDSHAFT PLATE VARIAX CLAVICLE 10 HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8084264
• Report Number: 0008031020-2018-00994
• Device Sequence Number: 13886271
• Product Code: HRS
• UDI-Device Identifier: 07613252441960
• UDI-Public: 07613252441960
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

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 Catalogue Number: 628310
• Device Lot Number: L05790
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 02/22/2019
• 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: 35 YR