MAUDE Adverse Event Report: CONMED LINVATEC POWERPRO PNEUMATIC MODULAR HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number PRO6150

Device Problem Intermittent Continuity (1121)

Patient Problem No Information (3190)

Event Type  No Answer Provided  

Manufacturer Narrative

Conmed received the powerpro pneumatic modular handpiece for evaluation on 26-oct-2015 and confirmed the report of intermittent power and will not stop.Visual inspection noted the trigger seal is dry from age.Mechanical testing of the returned handpiece found the motor torque is weakening and the trigger will not release fully because the trigger seal is preventing free movement of the trigger shaft.It appears that this handpiece failure is related to inadequate maintenance and normal wear and tear.This handpiece was manufactured on june 19, 2008 and has been in use for over 7 years.The last date of preventive maintenance or servicing by the manufacturer occurred on june 21, 2013.This handpiece has a recommended 12 month service interval and is approximately 1 year and 4 months overdue for preventive maintenance.Lack of preventive maintenance can cause device components to become worn and damaged over time.This failure mode is addressed in the fmea, and the safety risk has been found to be acceptable.The user manual contains the following recommendations for the care and maintenance of the powerpro pneumatic handpiece: regular and proper maintenance of your powerpro® handpieces are the best ways to protect your investment.It is essential that you have your powered surgical instruments serviced as scheduled in order to retain their optimum performance and reliability, which will reward you with safer, less problematic product performance over time.The recommended maintenance interval for service of your powerpro handpieces is every 12 months.Your authorized hall® surgical service department is the most knowledgeable about the powerpro instruments and will provide competent and efficient service.Service at conmed linvatec/hall surgical at the recommended service interval is mandatory to keep your product warranties in effect.Any services and/or repairs done by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure.

Event Description

The customer reported that during use of the powerpro pneumatic modular handpiece in a case, the handpiece had intermittent power and it would not stop causing patient impact.No further event details were provided and attempts to obtain additional event information have been unsuccessful.

• Brand Name: POWERPRO PNEUMATIC MODULAR HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5231053
• MDR Text Key: 31447115
• Report Number: 1017294-2015-00075
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: PRO6150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other