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

Catalog Number	53-1160
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A true evaluation could not be completed as there was very limited information provided by the end user.The product is not available for return, the lot number is unknown, and there are no pictures available.However, the complaint was originally reported to j&j (codman), which indicates that the device was purchased through codman or marked with the codman name.Symmetry surgical acquired the codman line in 2012.There has been a total of (b)(4) sold of this device since 2012 with 1 additional complaint recorded for similar occurrence.The root cause of the additional complaint was found to be wear and tear of the device with over 20 years of use.Based on the information provided above and the lack of information from the customer, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or corrective actions needed, a follow-up report will be submitted.The delay in the fda receiving this complaint was due to a change in esignature certificates.
Event or Problem Description
During a spinal discectomy with l5-s1 disc hernation, the extremity of the curved up disc rongeur was broken and a piece became stuck in the disc.After several attempts of the surgeon, the broken piece was recovered.

• Brand Name: SYMMETRY FERRIS-SMITH
• Common Device Name: IVD RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8676419
• Report Number: 3007208013-2019-00017
• Device Sequence Number: 1993350
• Product Code: HAE
• UDI-Device Identifier: 00887482021897
• UDI-Public: 00887482021897
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

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: 53-1160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1