MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 3MM FLUTED MATCHSTICK, 15CM; DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR

Catalog Number	MA15-8NS
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device serial/lot number is unknown; therefore, udi: (b)(4).Concomitant med products and therapy dates: attachment device, 01/01/2019.Device manufacture date is unknown.The device serial or lot number is unknown.The actual device was returned for evaluation.Quality engineering evaluated of the device, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to corrosion, debris and residue buildup in the attachment devices locking mechanism assembly which prevented the lock tabs from moving into place, which was due to improper cleaning (user error).If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported that the cutter device became stuck inside of the attachment device.During in-house engineering evaluation, it was determined that the cutter device was broken off below the laser marking and stuck inside of the attachment device.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 3MM FLUTED MATCHSTICK, 15CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9275655
• Report Number: 1045834-2019-54824
• Device Sequence Number: 1564997
• Product Code: HBE
• UDI-Device Identifier: 00845384004615
• UDI-Public: 00845384004615
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042783
• 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
• Report Date (Section B): 09/16/2019

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: MA15-8NS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1