MAUDE Adverse Event Report: SYMMETRY SURGICAL KARLIN SYMMETRY; NERVE HOOK

Catalog Number	46-3171
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the device is unknown.There has been a total of (b)(4) sold of all lots with 4 additional complaints recorded for similar occurrences.All other occurrences were significantly used and has significant wear and tear.The evaluation of the product is still anticipated and additional information regarding the patient outcome is still being requested.A follow up report will be submitted once we have received additional information of the product is returned for evaluation.
Event or Problem Description
The customer alleged " during an 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 a new instrument.The neptune filter was taken apart to search for the tip in the event that it had been removed from the patient through suction.The filter contents were searched, btu the instrument tip was not found.An ap x-ray was taken at the end of the procedure and reviewed by the surgeon.There was no clear determination of any metal retained inside the patient.The surgeon ordered a ct scan to look for any retained objects.The ct scan found the remaining hook piece inside the patient's surgical site.The dr has met with the patient again and is recommending the piece be removed in the or due to the risk of scar tissue build up.
Additional Manufacturer Narrative
The additional surgery was completed three days after the incident.The piece was successfully removed from the patient.The patient was sent home and has since recovered.After multiple attempts, the device has not been returned for evaluation.The lot number was not provided and pictures were not provided.Without the device or lot number, an investigation cannot be completed.Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: KARLIN SYMMETRY
• Common Device Name: NERVE HOOK
• Manufacturer (Section D): SYMMETRY SURGICAL; 3034 owen drive; antioch TN 37013
• MDR Report Key: 12178091
• Report Number: 3007208013-2021-00021
• Device Sequence Number: 4301624
• Product Code: GDG
• UDI-Device Identifier: 00887482014851
• UDI-Public: 00887482014851
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 46-3171
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention