MAUDE Adverse Event Report: STRYKER GMBH LOCKING COMPRESSION PLATE BROAD AXSOS 18 HOLE / L335MM 5.0MM LOCKING SET; PLATE, FIXATION, BONE

Catalog Number	427148S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
A broken explanted locking compression plate was returned to stryker with no event information or return materials authorisation and was passed to the rma department.
Additional Manufacturer Narrative
The reported event that locking compression plate broad axsos 18 hole / l335mm 5.0mm locking set was alleged of 'implant breakage after surgery' could be confirmed, since the device was returned and the plate is indeed broken in two.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.It is important to have more information such as the patient's details, the patient's activity level, the x-rays, the implantation and explantation dates.To determine the exact root cause of the event.Nevertheless, one of the most probable root causes based on the device inspection is fatigue / overload, as well as the extreme bending of the device, which must have reduced the mechanical characteristics of the device.Indeed, this root cause is confirmed by the results of the visual inspection, which showed that the plate is very highly bended at the level of the first 4 holes, on the opposite side to the one where the breakage occured.A microscope inspection of the device shows 2 surface breakages: in one, bright surfaces prove that the plate broke on one side of the 5th oblong hole first, in such a way that the two parts of the plate rubbed against each other for some cycles, before the plate completely broke.Furthermore, some yellowish traces can be noticed, which look like rust, proving again that the plate was fractured for a while before breaking completely.The second surface of breakage does not present bright surfaces, but only greyish surfaces where some "waves" can be noticed, which is typical of a fatigue fracture.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.
Event or Problem Description
A broken explanted locking compression plate was returned to stryker with no event information or return materials authorisation and was passed to the rma department.

• Brand Name: LOCKING COMPRESSION PLATE BROAD AXSOS 18 HOLE / L335MM 5.0MM LOCKING SET
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7588934
• Report Number: 0008031020-2018-00455
• Device Sequence Number: 1897788
• Product Code: HRS
• UDI-Device Identifier: 07613154322343
• UDI-Public: 07613154322343
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K060514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 427148S
• Device Lot Number: V03559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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: Other