MAUDE Adverse Event Report: SYMMETRY SURGUCAL INC; CERVICAL CURETTE

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2018

Event Type  Injury  

Manufacturer Narrative

The product code and lot number is unknown as the product code has been rubbed off the instrument, however the customer also reported that the instrument is over 20 years old.The customer will be returning the device and we will be able to determine the cup size and part number.Once we have obtained additional information, a follow-up report will be submitted.(b)(6).(b)(4).The delay in the fda receiving this complaint was due to a change in e-signature certificates.

Event Description

During a cervical spine surgery, the tip of the curette broke off and fell into the patient.The piece was successfully removed with no harm to the patient.

Manufacturer Narrative

The lot number and purchase information for the instrument involved in this incident is unknown.Customer has purchased 19 of part # 66-1025 since 2013.Customer reported that while the instrument was in use, the patient suffered an epidural hematoma and an emergency craniotomy had to be performed.The customer did not return the complaint questionnaire and could not report on the condition of the patient or the date of the event.Customer reported that they did not quarantine instrument involved in the incident and part is not going to be returned to quality for evaluation.Customer reported that they were not actively using the test bar provided with this instrument as it had become lost.The test bar allows the spring-loaded point to be checked for proper action and also provides protection for the points when the tong is not in use.Customer should inspect instruments before and after use to determine the extent of wear and tear to the pins.If pins show wear and/or are dull, the customer is advised to replace them.The customer was advised to also replace their lost test bar(s).Customer was advised to refer to the ifu (b)(4) for safe and effective use of the device.Our ifu warns that an epidural hematoma is a complication that may occur if the instructions for use are disregarded in any way.Due to the lack of information received from the customer, this can be seen as the final report.If additional information is obtained that alleges the need for corrective actions or alleges any additional patient involvement a follow-up report will be submitted.The delay in the fda receiving this complaint was due to a change in esignature certificates.

• Type of Device: CERVICAL CURETTE
• Manufacturer (Section D): SYMMETRY SURGUCAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8676188
• MDR Text Key: 148273050
• Report Number: 3007208013-2019-00008
• Device Sequence Number: 1
• Product Code: FZS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1