MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DUAL CUT (16.5 X 0.38 X 34.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	5400003104
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during an osteotomy procedure, two cutting tooth fragments broke from the blade.It was also reported there was a minor delay as a result of this event, one cutting tooth was retrieved and destroyed and the second cutting tooth remained in the patient.It was further reported that there were no adverse consequences and the procedure was completed successfully.
Event or Problem Description
It was reported that during an osteotomy procedure, two cutting tooth fragments broke from the blade.It was also reported there was a minor delay as a result of this event, one cutting tooth was retrieved and destroyed and the second cutting tooth remained in the patient.It was further reported that there were no adverse consequences and the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation results indicate that that that teeth fractured due to contacting metal (such as cut guides or surgical instruments) during operation.The striations on the blades surface can be seen to bend inwards towards the centre of the blade.This suggests that the tooth was bent in the same direction before or when the tooth fractured away from the rest of the blade.The ifu of handpieces associated with this device warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the blade.Excessive pressure may bend or fracture the blade and cause tissue damage and/or loss of tactile control".The quality investigation is complete.

• Brand Name: MICRO DUAL CUT (16.5 X 0.38 X 34.5MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8432137
• Report Number: 0001811755-2019-00869
• Device Sequence Number: 11038925
• Product Code: GFA
• UDI-Device Identifier: 04546540401779
• UDI-Public: 04546540401779
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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 Expiration Date: 03/01/2023
• Device Catalogue Number: 5400003104
• Device Lot Number: 18084027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1