MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BLACK MAX HANDPIECE; MOTOR, DRILL, PNEUMATIC

Catalog Number BLACKMAX-N

Device Problems Misconnection (1399); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer reported that the team has overheating during commissioning.The outer hose provided both ends mismatch in the connection of air exhaust valve.Preventive service required general cleaning and decontamination.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to synthes ous service and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.During pre-repair assessment performed by a technician, functional testing was performed and revealed the rotation speed was low, the hose leaked, and the motor was worn.This was attributed to normal wear.The device was repaired and returned to the customer.

• Brand Name: BLACK MAX HANDPIECE
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 4179434
• MDR Text Key: 5096323
• Report Number: 1045834-2014-14517
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: PK831756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BLACKMAX-N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1