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

Model Number	1100000000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/22/2019
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 an autopsy procedure, when opening the skull, the blade broke at the mount.It was also reported that there was a few minutes delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.It was also reported that the user was not aware that the blade is a single use blade.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned.
Event or Problem Description
It was reported that during an autopsy procedure, when opening the skull, the blade broke at the mount.It was also reported that there was a few minutes delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.It was also reported that the user was not aware that the blade is a single use blade.
Event or Problem Description
It was reported that during an autopsy procedure, when opening the skull, the blade broke at the mount.It was also reported that there was a few minutes delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.It was also reported that the user was not aware that the blade is a single use blade.
Additional Manufacturer Narrative
H6; the reported blade involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The blade was evaluated by product engineering who concluded that upon inspection it was noted that the blade is bent on the plane perpendicular to the arbor.This suggests the application of a bending moment while in use, which in turn could cause this failure mode.It is reasonable to conclude that the application of a bending moment while in use could cause the blade to fail as observed.

• 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: 9335332
• Report Number: 0001811755-2019-03772
• Device Sequence Number: 11417127
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2020

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: 05/01/2024
• Device Model Number: 1100000000
• Device Catalogue Number: 1100000000
• Device Lot Number: 19141017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 01/31/2020; 06/26/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 02/03/2020; 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1