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 Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the plate broke between week 2 and week 6 after the implantation.Postoperatively, no screw loosening was detected.The plate had to be removed and a new arthrodesis had to be done.
Event or Problem Description
It was reported that the plate broke between week 2 and week 6 after the implantation.Postoperatively, no screw loosening was detected.The plate had to be removed and a new arthrodesis had to be done.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by fatigue of the material following overloading.The visual inspection showed that the plate broke at the level of the compression ramp.The microscopic investigation 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.As a reminder, the ifu states: "]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." 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.

• 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: 8453745
• Report Number: 0008031020-2019-00315
• Device Sequence Number: 18939912
• Product Code: HRS
• UDI-Device Identifier: 07613252260608
• UDI-Public: 07613252260608
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/01/2019

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: Y12312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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: 61 YR
• Patient Weight: 80