MAUDE Adverse Event Report: SYMMETRY SURGICAL INC KARLIN MICRO NERVE HOOK; HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Lot Number 46-3171

Device Problems Break (1069); Entrapment of Device (1212); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/15/2021

Event Type  Injury  

Event Description

During anterior cervical discectomy and fusion the 0.7 micro nerve hook tip broke while in use inside the patient.The instrument was removed from the field by the scrub and replaced with new instrument.The neptune filter was broken apart by the circulator to search for the item in the event it had been removed from the patient through the suction device.The filter contents were searched, but the instrument tip was not found.An ap x-ray was taken at the end of procedure and reviewed by the surgeon (uploaded to pacs).There was not a clear determination of any metal retained inside the patient.The surgeon will order a ct to look for any retained objects.Spoke with operating room nm and surgeon at length.This tool was being used in its intended fashion, during a routine procedure.Dr.Coester reports he was removing soft tissue from the cervical spine area and the hook broke off.The proper retained body procedure was followed, the body did not show on x-ray.He spoke with the pt this morning and explained the complication, recommending a ct to evaluate the surgical site.The ct found the remaining hook piece to be in the patient's surgical site.Dr.Coester has met with the patient again and is recommending the piece be removed in the operating room, sooner than later, due to the risk of scar tissue build up.He explains that, if left in the surgical site, it will be a problem in the future, if she were to need an mri.Fda safety report id # (b)(4).

• Brand Name: KARLIN MICRO NERVE HOOK
• Type of Device: HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SYMMETRY SURGICAL INC; antioch TN 37013
• MDR Report Key: 12058818
• MDR Text Key: 258508405
• Report Number: MW5102114
• Device Sequence Number: 1
• Product Code: GDG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 46-3171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR