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

Catalog Number	0940023000
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that following removal of a cast from a infants arm, burn marks were observed on the patients arm.It was also reported that the event did not cause a delay and the procedure was completed successfully.
Additional Manufacturer Narrative
The reported event, for burn, as a result of the use of the ion nitrided blade, was not confirmed as the ion nitrided blade was not returned for evaluation.Without the ion nitrided blade, the root cause cannot be determined.Device not available for return.
Event or Problem Description
It was reported that following removal of a cast from a infants arm, burn marks were observed on the patients arm.It was also reported that the event did not cause a delay and the procedure was completed successfully.

• 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: 7847431
• Report Number: 0001811755-2018-01637
• Device Sequence Number: 1351390
• Product Code: LGH
• UDI-Device Identifier: 04546540132253
• UDI-Public: 04546540132253
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0940023000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0940000000 S/N: (B)(4); 0986000000 S/N: (B)(4)