MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE MTP, RIGHT ANCHORAGE; PLATE, FIXATION, BONE

Catalog Number	PLP14342
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
Breakage of the plate without trauma.
Event or Problem Description
Breakage of the plate without trauma.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as the patient's activity level, as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on complaint history review, some possible root causes are, but are not limited to: an early loading of the device, before bone consolidation.The ifu says: "the product does not allow the immediate resumption of activity by the patient and is not designed to support an immediate load.Immobilization is necessary during the osteosynthesis." the use of the device on an obese patient which could have shortened the lifetime of the device.The ifu reminds: "excess weight, intense professional or sporting physical activity that exposes the implant to excessive or repeated loads." the bending of a cp plate, which is against operative technique guide instructions.The operative technique guide states: "when utilizing the plate benders, the following guidelines should be adhered to: do not apply on cp plates.Ensure the threaded holes of the plate are not disrupted during bending technique.It is not recommended to bend at the plate extremities.Plates should only be bent in one direction.Do not re-bend plates" 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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Breakage of the plate without trauma.
Additional Manufacturer Narrative
The reported event could be confirmed.The visual inspection showed that the plate is indeed broken.The microscope investigation showed a dull and fibrous fracture surface also necking is noticed on the fracture contour.This is a typical sign that a large force was applied to the part leading to such a breakage (ductile overload fracture).More detailed information about the complaint event such as the patient's activity level, as well as the x-rays must be available in order to determine the root cause of the complaint event.However, based on complaint history review and the visual inspection of the reported part, some possible root causes are, but are not limited to: an early loading of the device, before bone consolidation.As a reminder, the ifu says: "the product does not allow the immediate resumption of activity by the patient and is not designed to support an immediate load.Immobilization is necessary during the osteosynthesis." the use of the device on an obese patient which could have shortened the lifetime of the device.The ifu reminds: "excess weight, intense professional or sporting physical activity that exposes the implant to excessive or repeated loads." the bending of a cp plate, which is against operative technique instructions.The operative technique states: "when utilizing the plate benders, the following guidelines should be adhered to: do not apply on cp plates ensure the threaded holes of the plate are not disrupted during bending technique it is not recommended to bend at the plate extremities plates should only be bent in one direction do not re-bend plates." 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 additional information is provided, the investigation will be reassessed.

• Brand Name: CROSS PLATE MTP, RIGHT ANCHORAGE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8457286
• Report Number: 0008031020-2019-00326
• Device Sequence Number: 18921091
• Product Code: HRS
• UDI-Device Identifier: 07613252260608
• UDI-Public: 07613252260608
• Combination Product (Y/N): N
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2019

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 Catalogue Number: PLP14342
• Device Lot Number: V46451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 06/21/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 06/03/2019; 07/12/2019
• 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