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

Model Number	5100037902
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/27/2019
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 the blade broke at the distal end during a procedure.No further information was provided.
Event or Problem Description
It was reported that the blade broke at the distal end during a procedure.No further information was provided.
Additional Manufacturer Narrative
H6; the blade reported involved in this event was not returned for evaluation.However, photographic evidence was provided of a broken blade where the reported event of blade breakage was confirmed.Without the blade, the root cause cannot be determined.Device not available for return.

• 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: 9606736
• Report Number: 0001811755-2020-00098
• Device Sequence Number: 2721047
• Product Code: GFA
• UDI-Device Identifier: 04546540466822
• UDI-Public: 04546540466822
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 08/01/2023
• Device Model Number: 5100037902
• Device Catalogue Number: 5100037902
• Device Lot Number: 18213017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1