FDA Adverse Event Injury Summary report: N

OSTEOTOME GUARDED 180MM STR CLAOUE

MDR report key: 1930621 · Received December 16, 2010

Report

Report Number: 9680837-2010-00013
Event Type: Injury
Date Received: December 16, 2010
Date of Event: November 9, 2010
Report Date: November 22, 2010
Manufacturer: MEDTRONIC XOMED INSTRUMENTS
Product Code: LRC
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF THE COMPLAINT HISTORY INDICATED THIS IS THE FIRST COMPLAINT OF THIS NATURE FOR THE REPORTED INSTRUMENT. THE PRODUCT WAS BEING USED FOR TREATMENT AND NOT FOR DIAGNOSIS. THE INSTRUMENT WAS RETURNED TO THE MEDTRONIC XOMED INSTRUMENTS (MXI), (B)(4) FOR ANALYSIS. MXI EXAMINED THE PRODUCT, BUT WAS UNABLE TO DETERMINE THE LOT NUMBER OF THE RETURNED INSTRUMENT. PHYSICAL EVIDENCE INDICATES THIS INSTRUMENT WAS MANUFACTURED MORE THAN 18 YEARS AGO. MEDTRONIC XOMED INSTRUMENTS HAS NOTIFIED THE HOSPITAL BY PHONE AND EMAIL THAT THIS INSTRUMENT IS CONSTRUCTED OF FERROMAGNETIC STAINLESS STEEL; THEREFORE, MRI SHOULD NOT BE USED ON THIS PATIENT.

Description of Event or Problem · 1

DURING A SEPTORHINOPLASTY THE OSTEOTOME BROKE IN THE PATIENT'S NOSE. THE FRAGMENT WAS TOO DEEP TO RETRIEVE WITHOUT ADDITIONAL INVASIVE PROCEDURES AND REMAINS IN THE PATIENT. THERE WERE NO FURTHER REPORTED CONSEQUENCES TO THE PATIENT. NO ADDITIONAL PROCEDURES ARE SCHEDULED AT THIS TIME TO REMOVE THE FRAGMENT. THE HOSPITAL INDICATED IT WOULD CONDUCT ADDITIONAL IMAGING TO DETERMINE IF ANY FOLLOW-UP WAS NECESSARY. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT WILL BE REPORTED ON A SUPPLEMENTAL MDR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OSTEOTOME GUARDED 180MM STR CLAOUE	INSTRUMENT, ENT MANUAL SURGICAL	LRC	MEDTRONIC XOMED INSTRUMENTS	CP305	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	00054 DA		Other