MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2108 SERIES SAGITTAL BLADE (19.5 X 1.27 X 81.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	2108109000S9
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of product to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, that inner pack of the blade was sealed with the outer pack and blade would not drop down into the sterile field.It was also reported that there was no delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.
Additional Manufacturer Narrative
The reported event, for packaging sterility issue, was not confirmed as the product was not received for evaluation.Without the product, the root cause cannot be determined.Device not received by manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, that inner pack of the blade was sealed with the outer pack and blade would not drop down into the sterile field.It was also reported that there was no delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.

• Brand Name: 2108 SERIES SAGITTAL BLADE (19.5 X 1.27 X 81.0MM)
• 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: 8491891
• Report Number: 0001811755-2019-01098
• Device Sequence Number: 16501941
• Product Code: GFA
• UDI-Device Identifier: 07613153090915
• UDI-Public: 07613153090915
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/04/2019

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 Catalogue Number: 2108109000S9
• Device Lot Number: 19003017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1