MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.27X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	6125127090
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2020
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 at the hospital, small puncture holes were identified on the packaging of two devices.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 second package.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during incoming inspection at the hospital, small puncture holes were identified on the packaging of two devices.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 second package.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.27X90MM)
• 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: 10295128
• Report Number: 0001811755-2020-01747
• Device Sequence Number: 2432699
• Product Code: GFA
• UDI-Device Identifier: 04546540501516
• UDI-Public: 04546540501516
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 6125127090
• Device Catalogue Number: 6125127090
• Device Lot Number: 20106027
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1