MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LARGE SECTION BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	1100000000
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2019
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 set preparing for opening a cranium during an autopsy, the blade broke at the mount.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 also reported that this single use blade was used ten times.
Additional Manufacturer Narrative
Investigation results indicate that this was a single use blade that was reused.The quality investigation is complete.Device not returned.
Event or Problem Description
It was reported that during set preparing for opening a cranium during an autopsy, the blade broke at the mount.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 also reported that this single use blade was used ten times.

• Brand Name: LARGE SECTION BLADE
• 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: 8905773
• Report Number: 0001811755-2019-02716
• Device Sequence Number: 2730499
• Product Code: GFA
• UDI-Device Identifier: 04546540024978
• UDI-Public: 04546540024978
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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: 03/01/2024
• Device Catalogue Number: 1100000000
• Device Lot Number: 19087027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1