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	11/19/2018
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.
Event or Problem Description
The following event was reported to (b)(6): mtp arthrodesis plate right foot was implanted on (b)(6) 2016, was found broken in the patient's foot.Patient was revised to new plate.
Additional Manufacturer Narrative
Correction: section d4 (lot #), d10, h3.The reported event could be confirmed, since the device was returned for evaluation and matches with the alleged failure.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused mainly because of non-union of the bone, as bone was not healed even after 2+ years and hence surgeon had to implant a new plate.The visual and microscopic inspection revealed that the breakage is a typical fatigue fracture.The dark colored region and the shiny surface are the two indicators for the fatigue fracture type.An extended and or an early overloading of the plate can lead to such event.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.In this case, as the patient is an 80 years old female, most probably bone quality could be poor.The anchorage plate system is an internal fixation system which shall fix bone segments in a correct position until sufficient bone consolidation is achieved, usually after at least 8 weeks of immobilization.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.In the case of an overloading or due to poor implantation technique implant failure may result.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
The following event was reported to the ansm: " mtp arthrodesis plate right foot was implanted on (b)(6)2016 , was found broken in the patient's foot.Patient was revised to new plate.

• 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: 8566377
• Report Number: 0008031020-2019-00377
• Device Sequence Number: 1998413
• Product Code: HRS
• UDI-Device Identifier: 07613252260608
• UDI-Public: 07613252260608
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: V08494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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: 80 YR
• Patient Weight: 80