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

Catalog Number	0940023000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that following the removal of a cast it was observed that the customer was cut or burned.No further information was provided.
Additional Manufacturer Narrative
Investigation results indicate that excessive use of the blade along with using the handpiece in a continuous linear motion may have contributed to the abrasion.The ifu for cast cutter blades has the following warning; ¿cut with an up and down motion.Straight cutting may cut or burn the patient.¿ the quality investigation is complete.
Event or Problem Description
It was reported that following the removal of a cast it was observed that the customer was cut or burned.No further information was provided.

• 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: 8687208
• Report Number: 0001811755-2019-01950
• Device Sequence Number: 19422928
• Product Code: LGH
• UDI-Device Identifier: 04546540132253
• UDI-Public: 04546540132253
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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 Catalogue Number: 0940023000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1