MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DUAL CUT SAGITTAL BLADE(11X1.19X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	4111127090
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.Discarded.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed during preparation for a surgical procedure.It was further reported that there was no patient involvement, no delay and no adverse consequences as a result of this event.

• Brand Name: DUAL CUT SAGITTAL BLADE(11X1.19X90MM)
• 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: 7913886
• Report Number: 0001811755-2018-01686
• Device Sequence Number: 1513753
• Product Code: GFA
• UDI-Device Identifier: 04546540216816
• UDI-Public: 04546540216816
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/27/2018

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: 4111127090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1