MAUDE Adverse Event Report: SYMMETRY SURICAL INC SYMMETRY CLASSIC PLUS; NEEDLE HOLDER

Catalog Number	36-2016
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested but not received regarding the nature of the damage and age of the instrument.We are also waiting to hear the condition of the patient and long-term effects.This customer has purchased 1,028 this product code since 2012.Symmetry surgical acquired this codman product in 2012 and the customer likely purchased the product prior to 2012 as well.There has been a total of (b)(4) sold of all lots of this product since 2012 with 2 additional complaints recorded for the inserts breaking off.The customer stated that the needle holder was broken, however, they have not provided details regarding where the device was broken.A follow up report will be submitted once additional information has been obtained.User facility report# (b)(4).
Event or Problem Description
The customer alleged that the patient underwent a craniotomy for epidural hematoma removal.Upon post-operative ct scans, it was noted that there was a metallic density seen over the bone in the subgaleal space.Upon investigation the instrument kit used for the procedure was obtained and it was discovered that there was a broken needle holder.The piece was not able to be retrieved due to an unrelated health condition.
Additional Manufacturer Narrative
After multiple follow ups no additional information was received from the user facility.The lot number was never provided, the device was not returned, and the pictures were not provided.Without this information, an investigation cannot be completed.Due to the lack of information low complaint probability, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any other patient involvement or the need for corrective actions a follow up report will be submitted.

• Brand Name: SYMMETRY CLASSIC PLUS
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 10985163
• Report Number: 3007208013-2020-00039
• Device Sequence Number: 19757712
• Product Code: HXK
• UDI-Device Identifier: 00887482009703
• UDI-Public: 00887482009703
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 36-2016
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1