MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY; NEEDLE HOLDER

Catalog Number 36-2018

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2023

Event Type  malfunction  

Event Description

The customer alleged that during a decompression posterior lumbar with fusion extension to l1 and anterior lumbar interbody fusion with vascular assist, half of a jaw insert broke away from the jaw.The piece fell into the patient and was retrieved with no further harm to the patient.

Manufacturer Narrative

The complaint was confirmed via pictures provided by the customer.However, the picture provided did not show any of the markings on the device to determine the lot number of the device.The device was discarded after the pictures were taken.Therefore, the device cannot be returned and no more pictures can be taken.Without further informaiton, a true root cannot be determined.The complaint has been logged in the complaint system for tracking and trending.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional informaiton pertinent to the investigation, a subsequent follow up report will be submitted.There has been a total of 29,146 sold of all lots with one additional complaint recorded for the insert platform breaking off.Therefore, there is a low complaint rate.Received via user facility report# (b)(4).

Manufacturer Narrative

The customer notified symmetry on 10/09/2023 that the device was found and available for returned.Upon receiving the device, it was evaluated and confirmed to have a manufactured date of 143 ( march 2014).The device showed significant signs of wear and tear with significant damage to the jaw inserts.Based on the product review and the risk assessment no further actions are necessary.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: SYMMETRY
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 17785549
• MDR Text Key: 323923162
• Report Number: 3007208013-2023-00045
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

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: Health Professional
• Device Catalogue Number: 36-2018
• Device Lot Number: 143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1