MAUDE Adverse Event Report: STRYKER GMBH CALCANEUS STANDARD PLATE, LARGE; PLATE, FIXATION, BONE

Model Number	40-10116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/14/2018
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 patient's left calcaneus was revised due to a broken plate.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.
Additional Manufacturer Narrative
The reported event that calcaneus standard plate, large was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by bending the plate in a critical area.The user highly deformed the plate at the level of the oblong hole which is against indications.As per operative technique, excessive plate bending may lead to failure of the locking mechanism, and is not recommended.The plate bending pliers are designed to only be used in circular holes, and must not be used inside oval holes.The deformation of the plate at that level affected the fatigue abilities of the plate, causing the breakage.The visual inspection on the microscope confirms the explanation.The ifu also states, severe, and/or repeated bending of an implant, which may lead to implant fatigue and failure.The device inspection revealed the following.The calcaneus plate was returned with 4 cortical screws and 7 locking screws.The plate is broken in two at the level of one of the oval holes.The microscope inspection shows that on the level of one of the fracture surfaces, a dark area specific to fatigue fractures can be noticed.Further more, when put together the two pieces of the broken plate show that it was highly deformed at the level of the oval hole.This important re modeling of the plate at that level could have contributed to cause the plates' failure.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
It was reported that patient's left calcaneus was revised due to a broken plate.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: CALCANEUS STANDARD PLATE, LARGE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7410398
• Report Number: 0008031020-2018-00292
• Device Sequence Number: 1264677
• Product Code: HRS
• UDI-Device Identifier: 07613154627776
• UDI-Public: (01)07613154627776
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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 Model Number: 40-10116
• Device Catalogue Number: 40-10116
• Device Lot Number: 1000187115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 06/08/2018
• 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: Required Intervention