MAUDE Adverse Event Report: SYMMETRY SURGICAL INC FERRIS-SMITH; SYMMETRY RONGEUR, IVD

Model Number	53-1160
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the date code etched on the device, this instrument was manufactured sometime in 1986.The instrument also shows signs of wear consistent with use for a long period of time.Based on the age and condition of the returned instrument, it was determined that the root cause of the failure is normal wear and tear.
Event or Problem Description
Patient was hospitalized for the management of a herniated disc l5-s1.At the discectomy, the end of the clamp broke, a piece was identified at the disc level.After several attempts the remaining piece could be removed.

• Brand Name: FERRIS-SMITH
• Common Device Name: SYMMETRY RONGEUR, IVD
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7405206
• Report Number: 3007208013-2018-00004
• Device Sequence Number: 13685780
• Product Code: HAE
• UDI-Device Identifier: 00887482021897
• UDI-Public: 00887482021897
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2018

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 Model Number: 53-1160
• Device Catalogue Number: 53-1160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR