MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (18.0X0.97X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	6118097090
Medical Device Problem Codes	Delivered as Unsterile Product (1421); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/08/2020
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 incoming inspection, the customer noticed foreign material inside the package.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
B5: following inspection of the returned device, this is not a reportable event.H6: the quality investigation is complete.
Event or Problem Description
It was reported that during incoming inspection, the customer noticed foreign material inside the package.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.It was subsequently confirmed that there was no impact to the sterility of the package following inspection of the returned device.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X0.97X90MM)
• 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: 10178545
• Report Number: 0001811755-2020-01521
• Device Sequence Number: 2461583
• Product Code: GFA
• UDI-Device Identifier: 04546540501394
• UDI-Public: 04546540501394
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: Other
• Device Expiration Date: 05/01/2024
• Device Model Number: 6118097090
• Device Catalogue Number: 6118097090
• Device Lot Number: 19124017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1