MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2108 SERIES SAGITTAL BLADE (20.5 X 0.88 X 94.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2108109001S1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the blade broke.It was also reported there were no delays and no adverse consequences as a result of this event.No further information was available.
Additional Manufacturer Narrative
The quality investigation is complete.Device not returned.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the blade broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 2108 SERIES SAGITTAL BLADE (20.5 X 0.88 X 94.5MM)
• 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: 9733862
• Report Number: 0001811755-2020-00527
• Device Sequence Number: 3128781
• Product Code: GFA
• UDI-Device Identifier: 07613154354597
• UDI-Public: 07613154354597
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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 Model Number: 2108109001S1
• Device Catalogue Number: 2108109001S1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1