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

Model Number 628030S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that "on (b)(6) 2020, the patient underwent implantation of the subject plate due to clavicle fracture (right).On unknown date, the patient complained of pain which revealed broke of plate in x-rays.On (b)(6) 2021, revision of plate was performed.The patient was suspected of nonunion.".

Event Description

It was reported that "on (b)(6) 2020, the patient underwent implantation of the subject plate due to clavicle fracture (right).On unknown date, the patient complained of pain which revealed broke of plate in x-rays.On (b)(6) 2021, revision of plate was performed.The patient was suspected of nonunion.".

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: the received plate is broken at the 4th hole on the lateral side.The microscopic examination of the fracture surface reveals the fracture to be a typical fatigue fracture evident by a smooth topography.The origin of the crack was at the upper right corner of the hole and there are fatigue striations in this area.In general is the plate in a used condition, at all holes are slight deformations visible, which can be traced back to normal screw insertion/locking.There are slight scratches and some minor nicks on the plate surface visible, but afterwards it cannot be defined if they were caused during insertion or extraction of the plate.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation and available information, the root cause of the failure is deemed to be patient factor related.The breakage of the device after 5 months of implantation, is most likely to be caused due to overloading of the device due to the reported non-union.Presence of signs of a fatigue fracture and absence of any remarkable user induced damage to the device supports this cause.If any additional information is provided, the investigation will be reassessed.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 10 HOLE / RIGHT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11609302
• MDR Text Key: 243606101
• Report Number: 0008031020-2021-00122
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540686923
• UDI-Public: 04546540686923
• Combination Product (y/n): N
• PMA/PMN Number: K113760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 628030S
• Device Catalogue Number: 628030S
• Device Lot Number: D52359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR