MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY KERRISON; BLACK DIAMON MICRO CONVERTIBLE RONGEUR

Model Number 59-1200-BD

Device Problem Missing Value Reason (3192)

Patient Problem No Code Available (3191)

Event Date 11/16/2015

Event Type  No Answer Provided  

Event Description

During spine surgery a kerrision was used to extract bone and it was noted that the handle was loose and the set screw was missing.Manual retrieval of part from the wound was done.The instrument broke into two or more pieced during surgery, there was a delay in treatment.N o patient harm or potential harm to the patient as a result.Instrument was part of a trial evaluation.

• Brand Name: SYMMETRY KERRISON
• Type of Device: BLACK DIAMON MICRO CONVERTIBLE RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 5332379
• MDR Text Key: 34886834
• Report Number: 3007208013-2015-00037
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00887482105467
• UDI-Public: 00887482105467
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2015

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
• Device Operator: Other
• Device Model Number: 59-1200-BD
• Device Catalogue Number: 59-1200-BD
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/10/2015
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1