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

Model Number 53-1160

Device Problem Break (1069)

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

Event Date 02/26/2018

Event Type  malfunction  

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 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
• Type of Device: SYMMETRY RONGEUR, IVD
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen drive; antioch, TN 37013 ; 8002513000
• MDR Report Key: 7405206
• MDR Text Key: 105236301
• Report Number: 3007208013-2018-00004
• Device Sequence Number: 1
• Product Code: HAE
• UDI-Device Identifier: 00887482021897
• UDI-Public: 00887482021897
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1986
• 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 Age: 44 YR