MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2108 SERIES SAGITTAL BLADE (24.8 X 0.88 X 73.8MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2108105000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device, foreign material was identified in the pack.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
E1:initial reporter updated to health care professional.H6: the device was not returned for investigation.The quality investigation is complete.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device, foreign material was identified in the pack.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

• Brand Name: 2108 SERIES SAGITTAL BLADE (24.8 X 0.88 X 73.8MM)
• 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: 9495192
• Report Number: 0001811755-2019-04089
• Device Sequence Number: 13973122
• Product Code: GFA
• UDI-Device Identifier: 04546540042019
• UDI-Public: 04546540042019
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 2108105000
• Device Catalogue Number: 2108105000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1