FDA Adverse Event Injury Summary report: N

ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

MDR report key: 15580290 · Received October 11, 2022

Report

Report Number: 3013479847-2022-00003
Event Type: Injury
Date Received: October 11, 2022
Date of Event: September 3, 2018
Report Date: October 11, 2022
Manufacturer: SONEX HEALTH
Product Code: LXH
PMA / PMN Number: K192873
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

INJURIES TO NERVES IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL COMPLICATION OF THE CARPEL TUNNEL RELEASE PROCEDURE. THE REPORTED EVENT DATE IS AN APPROXIMATE DATE OF THE EVENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, THE LOT NUMBER WAS NOT REPORTED AND THEREFORE A REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED.

Description of Event or Problem · 0

THE PHYSICIAN HAD NICKED A NERVE DURING SURGERY. ABOUT 2 WEEKS POST-PROCEDURE DURING THERAPY THAT IS PART OF THE PHYSICIAN'S STANDARD PRACTICE, THE PATIENT HAD SYMPTOMS THAT WERE POTENTIALLY SUGGESTIVE OF A PROBLEM WITH THE 3RD DIGITAL NERVE, PRESUMABLY A REDUCTION IN SENSATION IN THE THIRD WEBSPACE. THE PHYSICIAN SAW THE PATIENT, EVALUATED, AND EXPLORED THE PATIENT WITH AN OPEN CTR AND NERVE EXPLORATION. AT THE TIME HE NOTED A PARTIAL LACERATION OF THE 3RD COMMON PALMAR DIGITAL NERVE AND PERFORMED AN EPINEURIAL REPAIR. THE PATIENT WAS FOLLOWED FOR ABOUT 6 MONTHS AND THE PATIENT RECOVERED "PROTECTIVE SENSATION". THE PHYSICIAN INDICATED THAT THE PATIENT SEEMED "SATISFIED" WITH THE OUTCOME AT THAT POINT. THERE IS NO REPORT OF DEVICE MALFUNCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2482032	ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)	CARPAL TUNNEL RELEASE SYSTEM,	LXH	SONEX HEALTH	600112-001

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK	Female	Required Intervention