MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 3MM FLUTED MATCHSTICK, 15CM; MOTOR, DRILL, ELECTRIC - HANDPIECE

Model Number	MA15-8NS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the burr device that was stuck in the attachment device was fractured.Therefore, the reported condition was confirmed.It was also determined that the bearings were worn out on the attachment device which caused the cutter to become stuck.The burr device was examined using 25x magnification and rechecked on an optical comparator.A full assessment of the device could not be performed due to the condition of the cutter was received.A review of the device history record was performed and no non-conformances were detected related to the reported condition.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported that the burr stuck was stuck in the attachment device.During in-house engineering evaluation, it was determined that the burr device was fractured.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event is unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Correction: this field was incorrectly marked as yes in the initial report.This field has been corrected to no.
Additional Manufacturer Narrative
Corrected data: the date the device was returned to the manufacturer was reported as 11/19/2018 in the initial report and has been updated to 11/27/2018.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3MM FLUTED MATCHSTICK, 15CM
• Common Device Name: MOTOR, DRILL, ELECTRIC - HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8140056
• Report Number: 1045834-2018-52359
• Device Sequence Number: 19304808
• Product Code: HBC
• UDI-Device Identifier: 00845384004615
• UDI-Public: (01)00845384004615(11)171115(10)L413126938
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2018

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: Health Professional
• Device Model Number: MA15-8NS
• Device Catalogue Number: MA15-8NS
• Device Lot Number: L413126938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/21/2019; 01/30/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/21/2019; 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1