MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 2.3MM FLUTED MATCHSTICK, 15CM; DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR

Catalog Number	MA15-8N
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device date of manufacture and serial/lot is unknown; therefore, udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once quality engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported from (b)(6) that during equipment inspection it was observed that the cutter device could not be inserted into the attachment device.During in-house engineering evaluation, it was determined that a piece of broken cutter was stuck inside of the attachment device.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 was unknown but was noted to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.Quality engineering evaluated the device and determined that the broken piece of the cutter device was stuck inside the attachment device due to the bearings and gears being worn out.The piece of broken cutter was broken off below the laser marking and identification of the cutter could not be identified.Therefore, the reported condition was confirmed.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.

• Brand Name: 2.3MM 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: 8349784
• Report Number: 1045834-2019-52896
• Device Sequence Number: 18877730
• Product Code: HBE
• UDI-Device Identifier: 00845384004615
• UDI-Public: 00845384004615
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: MA15-8N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1