MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FAN BLADE, OFFSET (19.0 X 0.38 X 41.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	5400134415
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the blade exited the handpiece.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
This initial mdr was initially filed in error.The event reported in this case was that the blade would not lock into the handpiece.Based on a review of previous events of fitting issues, such events have not caused or contributed to an adverse event or serious injury in patients or users and for future events to occur is unlikely to cause or contribute to a serious injury event.In this event, the blade could not be used and the fitting issue was detected prior to use.No reported adverse consequences to user or patient was reported.As a result this supplemental mdr will note that the initial was filed in error and such an event is not reportable.Device not available for return.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the blade exited the handpiece.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: FAN BLADE, OFFSET (19.0 X 0.38 X 41.5MM)
• 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: 9570260
• Report Number: 0001811755-2020-00036
• Device Sequence Number: 458987
• Product Code: GFA
• UDI-Device Identifier: 04546540467317
• UDI-Public: 04546540467317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/09/2020

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 Expiration Date: 09/01/2024
• Device Model Number: 5400134415
• Device Catalogue Number: 5400134415
• Device Lot Number: 19272027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1