MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2108 SERIES SAGITTAL BLADE (24.9 X 0.64 X 73.8MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	2108100000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during a tha (total hip arthroplasty), the blade broke.It was also reported that an x-ray was performed to locate the blade fragment which was removed during the procedure.It was further reported that the single use blade was re-used.It was also reported that there was a 60 minute delay as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
The definitive root cause could not be determined as the device was not returned for evaluation, however the re-use of a single use device may have caused or contributed to this event.
Event or Problem Description
It was reported that during a tha (total hip arthroplasty), the blade broke.It was also reported that an x-ray was performed to locate the blade fragment which was removed during the procedure.It was further reported that the single use blade was re-used.It was also reported that there was a 60 minute delay as a result of this event and the procedure was completed successfully.

• Brand Name: 2108 SERIES SAGITTAL BLADE (24.9 X 0.64 X 73.8MM)
• 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: 8047954
• Report Number: 0001811755-2018-02410
• Device Sequence Number: 1499087
• Product Code: GFA
• UDI-Device Identifier: 04546540041999
• UDI-Public: 04546540041999
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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 Catalogue Number: 2108100000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1