MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2108 SERIES SAGITTAL BLADE (20.7 X 0.88 X 85.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	2108109000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
Event or Problem Description
It was reported that during an orthopaedic procedure, the blade broke at the mount.It was also reported that there was a five minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation results indicate that the markings on the blade suggest that at some point during the procedure the blade was misloaded.Operating the blade while it is misloaded causes excessive force on the blade mounts which can cause cracks to form and lead to failure at the blade mount.The bend in the blade is most likely due to excessive force in the perpendicular direction to the longitudinal axis of the blade.The quality investigation is complete.
Event or Problem Description
It was reported that during an orthopaedic procedure, the blade broke at the mount.It was also reported that there was a five minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

• Brand Name: 2108 SERIES SAGITTAL BLADE (20.7 X 0.88 X 85.0MM)
• 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: 8208210
• Report Number: 0001811755-2019-00001
• Device Sequence Number: 16200433
• Product Code: GFA
• UDI-Device Identifier: 04546540042026
• UDI-Public: 04546540042026
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: 08/01/2023
• Device Catalogue Number: 2108109000
• Device Lot Number: 18218017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1