MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 20.2CM HEAVY DUTY X-LONG ATTCH; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number	XL-HD
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the reported condition was confirmed.It was determined that the bearings were worn out which created a situation where the cutter was not able to be released.This was because the bearings were no longer in axial alignment not allowing the cutter to pass through.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 prior to surgery, it was observed that the cutter device was jammed in the attachment and motor device.During in-house engineering evaluation, it was determined that the attachment device overheated, the color ring on the nose cone was discolored and the bearings were worn out.This event did not occur during surgery.There was no patient involvement.There were no reports of 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: 20.2CM HEAVY DUTY X-LONG ATTCH
• Common Device Name: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8363876
• Report Number: 1045834-2019-52948
• Device Sequence Number: 13934118
• Product Code: HBC
• UDI-Device Identifier: 00845384010630
• UDI-Public: 845384010630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011444
• 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): 01/08/2019

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: XL-HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1