MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.19X110.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL.

Model Number	6118119110
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once 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, prior to a procedure, the inner polybag was merged into the seal of the outer 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.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device, prior to a procedure, the inner polybag was merged into the seal of the outer 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
H6: the quality investigation is complete.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.19X110.0MM)
• 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: 10645825
• Report Number: 0001811755-2020-02623
• Device Sequence Number: 19490067
• Product Code: GFA
• UDI-Device Identifier: 04546540593368
• UDI-Public: 04546540593368
• Combination Product (Y/N): N
• 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): 10/22/2020

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 Expiration Date: 04/01/2025
• Device Model Number: 6118119110
• Device Catalogue Number: 6118119110
• Device Lot Number: 20118027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1