MAUDE Adverse Event Report: STRYKER GMBH LOCKING COMPRESSION PLATE AXSOS 10 HOLE / L136MM 4.0MM LOCKING SET; PLATE, FIXATION, BONE

Model Number	427010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly on (b)(6) 2019 the patient tripped, fell, and broke the humerus bone in her right arm and underwent surgery on (b)(6) 2019 with implantation of a compression plate.It is further alleged that on (b)(6) 2019 she "was in the process of pushing her hair back behind her ear when suddenly the compression plate snapped, causing her humerus bone to re-break, and the metal was pushing her bone to protrude outward and consequently causing her immense pain." allegedly the patient underwent revision surgery to repair the rebroken humerus bone and to reinstall a new compression plate.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly on (b)(6) 2019 the patient tripped, fell, and broke the humerus bone in her right arm and underwent surgery on (b)(6), 2019 with implantation of a compression plate.It is further alleged that on (b)(6) 2019 she "was in the process of pushing her hair back behind her ear when suddenly the compression plate snapped, causing her humerus bone to re-break, and the metal was pushing her bone to protrude outward and consequently causing her immense pain." allegedly the patient underwent revision surgery to repair the rebroken humerus bone and to reinstall a new compression plate.
Additional Manufacturer Narrative
Correction: please refer to section d- catalog, lot and gtin number, g1 reporting contact, h6 method, results code.The reported event could be confirmed, since the broken plate is visible on the received picture set.A device inspection was not possible since the affected device was not returned, the review of the received pictures has shown that the plate is broken apart at the 5th hole.The catalog- and as well the lot number can be confirmed.The pictures were reviewed by the internal chemistry laboratory, based on the pictures it can be stated that the fracture originated from the lower left hand corner.The overall fracture mode of this image is fatigue.However, complete fracture analysis requires the physical part and associated manufacturing details of the subassembly in focus to determine potential stress risers, inclusions, surface properties, etc.To investigate further and ultimately determine a most likely root cause.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.More detailed information, like patient detail, x-ray or operation reports, about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The evaluation of the pictures has shown that there was a fatigue breakage of the plate.In this relation following statement from the instructions for use can be mentioned: [these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.]" [original statements].If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING COMPRESSION PLATE AXSOS 10 HOLE / L136MM 4.0MM LOCKING SET
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12050046
• Report Number: 0008031020-2021-00269
• Device Sequence Number: 3647743
• Product Code: HRS
• UDI-Device Identifier: 07613154321131
• UDI-Public: 07613154321131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: 07/31/2016
• Device Model Number: 427010
• Device Catalogue Number: 427010S
• Device Lot Number: X22777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female