MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE MTP / VERSION V1 - LEFT; PLATE, FIXATION, BONE

Catalog Number	PLP10341
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/07/2019
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
Plate broke approx.10 weeks after implantation.Patient was revised.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by an overloading of the part.The inspection of the part confirmed that the plate is indeed broken.In fact, the microscope investigation showed a dull and fibrous surface.Furthermore, some necking was also noticed on the plate's fracture contour.This is a sign that an excessive force was applied to the part, leading to such a breakage.Moreover, based on the complaint history and the information given that the patient had tripped 2 weeks prior the event, the most common reason for the plate breakage is the biomechanical stress on the plate.The major reasons for stress on the plate would be: construction failure; wrong after care advice; patient causes (e.G.Insufficient bone stock, non-compliance).Therefore, this case is classified as a user related issue.The anchorage plate system is an internal fixation system which shall fix bone segments in a correct position until sufficient bone consolidation is achieved.The anchorage plating system is not intended to transmit full forces and bending moments of daily routine.Loading and weight-bearing have to be individually reduced.Influence factors for the required load reduction are: the type and the localization of fixation, the bone quality (e.G.Strong bone in younger patients vs.Osteoporotic bone), correct fixation technique (e.G.Correct dimension of the plate, correct positioning of the plate, sufficient length of the plate and the screws, sufficient bending of the plate, correct screw placement with sufficient insertion torque).Depending on these individual influencing factors the attending physician has to determine the maximum loading and has to limit the weight bearing respectively.This is part of the surgeon's education.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
Plate broke approx.10 weeks after implantation.Patient was revised.

• Brand Name: PLATE ANCHORAGE MTP / VERSION V1 - LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8554776
• Report Number: 0008031020-2019-00372
• Device Sequence Number: 2232732
• Product Code: HRS
• UDI-Device Identifier: 07613252260417
• UDI-Public: 07613252260417
• Combination Product (Y/N): N
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: PLP10341
• Device Lot Number: J23825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 04/07/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/21/2019
• 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
• Patient Age: 56 YR