MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.27X100MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	6125127100
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of three devices, it was noted that the seal was open upon receipt.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.This report is for the third package.
Additional Manufacturer Narrative
The reported event, for packaging not sealed, was not confirmed as the product and pack was not returned for evaluation.Without the blade and packaging, the root cause cannot be determined.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of three devices, it was noted that the seal was open upon receipt.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.This report is for the third package.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.27X100MM)
• 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: 8255580
• Report Number: 0001811755-2019-00154
• Device Sequence Number: 19311670
• Product Code: GFA
• UDI-Device Identifier: 04546540501523
• UDI-Public: 04546540501523
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/04/2019

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 Expiration Date: 09/01/2023
• Device Catalogue Number: 6125127100
• Device Lot Number: 18247037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2018
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1