MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE; INSTRUMENT

Catalog Number	62-18330
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that the in-situ plate cutter broke intra-operatively, while trying to cut a plate.No medical intervention, delay of surgery, or adverse consequences were reported for this event.
Additional Manufacturer Narrative
Correction: even though the device evaluation was anticipated, this device was lost in transit on its way to the investigation team in freiburg, germany.The reported event that the ¿in-situ cutter broke apart¿ could be confirmed based on the photo provided by the sales representative, showing that a piece of the blade has fractured off.However, as it was not returned to stryker freiburg for investigation, a detailed inspection of the device including e.G.A metallurgical examination was not possible and a root cause could not be determined.According to the risk management file, possible root causes could have been exemplarily: ¿ fatigue over lifetime.¿ application of unintended load.¿ inadequate user handling.Based on statistical evaluation there is no indication for any systematic design, material or manufacturing related issue.Therefore no corrective and/or preventive action is deemed necessary at this time.If further information regarding the event will be received, the complaint will be reopened and.The result revised.Device lost in transit to freiburg no evaluation conducted.
Event or Problem Description
It was reported that the in-situ plate cutter broke intra-operatively, while trying to cut a plate.No medical intervention, delay of surgery, or adverse consequences were reported for this event.

• Brand Name: IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7800795
• Report Number: 0008010177-2018-00075
• Device Sequence Number: 1351122
• Product Code: LXH
• UDI-Device Identifier: 04546540366719
• UDI-Public: 04546540366719
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 62-18330
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1