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

Model Number	628030S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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 or Problem 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.".
Additional 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11609302
• Report Number: 0008031020-2021-00122
• Device Sequence Number: 14275652
• Product Code: HRS
• UDI-Device Identifier: 04546540686923
• UDI-Public: 04546540686923
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 10/31/2024
• 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
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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: 47 YR