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

Model Number	62-18330
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by the company representative that when the surgeon was using the cutters to cut through a plate, the plate did not shear and instead the cutters began stripping away/fracturing in small increments.
Event or Problem Description
It was reported by the company representative that when the surgeon was using the cutters to cut through a plate, the plate did not shear and instead the cutters began stripping away/fracturing in small increments.
Additional Manufacturer Narrative
The reported event that ¿the tips crumbled¿ could be confirmed.The visual inspection showed that the tips of both cutting edges have fractured off.The associated fracture surfaces reveal fractures due to mechanical overloads.Furthermore, both cutting edges show damages throughout the whole cutting line.In specific, a small fragment has broken out of the cutting edge #1 and cutting edge #2 shows multiple damages such as grooves and deformations on several positions of the cutting edge, indicating several attempts to cut (too) hard objects.Overall, this results in an impaired cutting function of the device.Based on the characteristics of the fracture surfaces as well as the determined damages at the cutting edges, the root cause for the breakage can be attributed to a user related issue, most likely due to cutting inappropriate and / or too hard objects.The in-situ plater cutter is designed for cutting titanium plates up to 0.6mm thickness.Therefore, harder and thicker materials may exceed the mechanical strength of the device.Indications for any material, manufacturing or design related problems were not determined in the investigation.Therefore, no preventive and / or corrective action is required at this time.

• Brand Name: IN-SITU PLATE CUTTER, UPPERFACE/MIDFACE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 9575534
• Report Number: 0008010177-2020-00006
• Device Sequence Number: 16613777
• 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): 06/25/2020

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 Model Number: 62-18330
• Device Catalogue Number: 62-18330
• Device Lot Number: AF07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1