MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 8 HOLE / RIGHT; PLATE, FIXATION, BONE

Model Number	628028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.Retained by hospital.
Event or Problem Description
As reported: "patient's right clavicle plate part number 628028, lot f15574 broke following a non union.Only paperwork facility had on the initial surgery was that it was implanted in 2015." "the plate breakage was noticed via x-ray and the revision implant was a superior variax clavicle plate.".
Additional Manufacturer Narrative
The reported event could be confirmed.A device inspection was not possible since the affected device was not returned, but an image (post breakage) was shared which confirms the alleged breakage of the plate.The plate was found to be broken from a round hole.Slight deformation could be observed around the breakage.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.Although a device image was shared for evaluation, the complete device must be available for evaluation to determine the exact root cause of the failure.However, based on past complaints history and the fact that the plate broke after 5 years, the most probable root cause of the failure of the plate would be non-union of the fracture, causing additional load on the plate which is patient related.If the device or any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "patient's right clavicle plate part number 628028 lot f15574 broke following a non union.Only paperwork facility had on the initial surgery was that it was implanted in 2015." "[.] the plate breakage was noticed via x-ray and the revision implant was a superior variax clavicle plate.".

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 8 HOLE / RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10708430
• Report Number: 0008031020-2020-02350
• Device Sequence Number: 19743958
• Product Code: HRS
• UDI-Device Identifier: 07613252441977
• UDI-Public: 07613252441977
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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 Model Number: 628028
• Device Catalogue Number: 628028
• Device Lot Number: F15574
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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: 59 YR