MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ION NITRIDED BLADE; INSTRUMENT, CAST REMOVAL, AC-POWERED

Model Number	0940023000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/16/2019
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 via the customer that, they observed a broken blade within their inventory.It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement, no delay and no adverse consequences as a result of this event.
Additional Manufacturer Narrative
The reported event, for blade breakage, was not confirmed as the blade was not returned for evaluation.Without the blade, the root cause cannot be determined.Device not available for return.
Event or Problem Description
It was reported via the customer that, they observed a broken blade within their inventory.It was also reported that this event did not occur during a surgical procedure, and there was no patient involvement, no delay and no adverse consequences as a result of this event.

• Brand Name: ION NITRIDED BLADE
• Common Device Name: INSTRUMENT, CAST REMOVAL, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9318736
• Report Number: 0001811755-2019-03758
• Device Sequence Number: 559879
• Product Code: LGH
• UDI-Device Identifier: 04546540132253
• UDI-Public: 04546540132253
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 0940023000
• Device Catalogue Number: 0940023000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1