MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY KARLIN¿; KARLIN HOOK

Catalog Number	46-3171
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the lot number is unknown.The device is being returned, but the evaluation has not been started.A follow-up report will be submitted once we receive more information.
Event or Problem Description
During the case, the cervical karlin currette micro hook broke and the piece fell into the patient.An intraoperative x-ray confirmed that all pieces were retrieved.There was no harm to the patient and no delay as a result.
Additional Manufacturer Narrative
Upon receiving the returned device, it was noted that the device had significant signs of wear and tear.The lot code on the device is "084" which indicates that it was manufactured in april 2008 and has had atleast 10 years of use.A hardness evaluation was completed and determined that the hardness of the device was 47.4 hrc which is within specification per the product drawings and intended use of the device.There have been two additional complaints recorded for a similar issue.In both cases the devices had been in use for over 5 years.Based on our investigation, it can be determined that the damage occurred due to wear and tear of the device over years of use.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions a follow up report will be submitted.

• Brand Name: SYMMETRY KARLIN¿
• Common Device Name: KARLIN HOOK
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8905988
• Report Number: 3007208013-2019-00030
• Device Sequence Number: 1828936
• Product Code: GDG
• UDI-Device Identifier: 00887482014851
• UDI-Public: 00887482014851
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 46-3171
• Device Lot Number: 084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1