MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LEFT IBO BLADE (10.0 X 0.38MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	5100037902
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
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 via medwatch 5085840 that during a surgical procedure, the saw blade broke from the stem.It was also reported that the broken blade was checked and was intact, no other fragments of the equipment was found.It was further reported that there were no adverse consequences as a result of this event.
Event or Problem Description
It was reported via medwatch 5085840 that during a surgical procedure, the saw blade broke from the stem.It was also reported that the broken blade was checked and was intact, no other fragments of the equipment was found.It was further reported that there were no adverse consequences as a result of this event.
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.

• Brand Name: LEFT IBO BLADE (10.0 X 0.38MM)
• 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: 8623430
• Report Number: 0001811755-2019-01738
• Device Sequence Number: 2293162
• Product Code: GFA
• UDI-Device Identifier: 04546540466822
• UDI-Public: 04546540466822
• 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: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: No Information
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 5100037902
• Device Lot Number: 17157017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1