MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.0MM EGG RESURFACING TOOL; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	1900015040
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device evaluation results.
Event or Problem Description
It was reported that during a foot/ankle procedure the bur broke at the cutting end.It was further reported that there was a delay of less than 5 minutes to obtain an alternative device.It was also reported that there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a foot/ankle procedure the bur broke at the cutting end.It was further reported that there was a delay of less than 5 minutes to obtain an alternative device.It was also reported that there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation results indicate that contact with metal during use could lead to the failure observed.The quality investigation is complete.

• Brand Name: 4.0MM EGG RESURFACING TOOL
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9285965
• Report Number: 0001811755-2019-03663
• Device Sequence Number: 14041486
• Product Code: GFF
• UDI-Device Identifier: 07613327376319
• UDI-Public: 07613327376319
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 1900015040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1