MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. RAPIDCLEAN MICRO KERRISON RONGEUR; CERAMIC COATED CONVERTIBLE MCRO KERRISON RONGEUR

Model Number	58-2180-BD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices were returned to the mfr for evaluation, symmetry sales rep and mfr stated that all instruments were not well maintained.The instruments were all very dry and showed no signs of being lubricated.The (symmetry) sales rep has worked with the customer to educate on how to care for these instruments.Symmetry is in the process of implementing an updated ifu that will indicate where to lubricate these instruments to prevent the screw from backing out.
Event or Problem Description
Micro kerrison rongeur screw came out during a case and fell onto the floor.However, the screw was never returned to spd so facility cannot return with the device.

• Brand Name: RAPIDCLEAN MICRO KERRISON RONGEUR
• Common Device Name: CERAMIC COATED CONVERTIBLE MCRO KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013 0000
• MDR Report Key: 5404350
• Report Number: 3007208013-2016-00002
• Device Sequence Number: 10823359
• Product Code: HTX
• UDI-Device Identifier: 00887482102213
• UDI-Public: 00887482102213
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Repair,Replace
• Report Date (Section B): 01/12/2016

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: No Information
• Device Model Number: 58-2180-BD
• Device Catalogue Number: 58-2180-BD
• Device Lot Number: BJ0714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Distributor Facility Aware Date: 12/17/2015
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1