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	03/21/2019
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 cutter fractured on the rivet hole during a craniotomy case.The cutter was used to cut 1.7mm plate.
Additional Manufacturer Narrative
The investigation shows that the product subject to the complaint had reached its life time at the event date of the reported incident.The relevant quality documents indicate that the product was manufactured according to specifications and was accepted into stock without any discrepancies.There is no indication for a quality issue with the article in question, nor is there any indication for a deviation from the defined quality specifications within development and or manufacturing.No indications for unusual or unexpected circumstances could be identified.Moreover, it is to be concluded that the reported incident originated from a common case of wear and tear resulting from aging as it is to be expected with mechanical medical devices subject to reprocessing after reaching their life time, not making any further action necessary.This complaint will be considered in statistical analyses at frequent intervals.
Event or Problem Description
It was reported that the in-situ cutter fractured on the rivet hole during a craniotomy case.The cutter was used to cut 1.7mm plate.

• 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: 8464852
• Report Number: 0008010177-2019-00014
• Device Sequence Number: 11038844
• Product Code: LXH
• UDI-Device Identifier: 04546540366719
• UDI-Public: 04546540366719
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/20/2019

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/FROM STOCKED CONSIGNME
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1