MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY BACKHAUS; TOWEL CLAMP

Model Number	33-5005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility stated they will not return the device to the manufacturer for evaluation.
Event or Problem Description
At closure of surgery, the operating room team identified the towel clip used had an incomplete tip, it appeared to be broken.Unknown when the clip broke.Additional anesthesia was administered and x-rays were taken to locate the broken tip, the tip was not found.The patient was okay as far as they know.Device will not be returned for evaluation to manufacturer.

• Brand Name: SYMMETRY BACKHAUS
• Common Device Name: TOWEL CLAMP
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7512957
• Report Number: 3007208013-2018-00005
• Device Sequence Number: 19138837
• Product Code: HXD
• UDI-Device Identifier: 00887482008805
• UDI-Public: 00887482008805
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: 33-5005
• Device Catalogue Number: 33-5005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1