FDA Adverse Event Injury Summary report: N

DYONICS 25

MDR report key: 3874082 · Received June 16, 2014

Report

Report Number: 1643264-2014-00007
Event Type: Injury
Date Received: June 16, 2014
Date of Event: May 16, 2014
Report Date: May 17, 2014
Manufacturer: OKLAHOMA CITY MANUFACTURING SITE
Product Code: HAB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT FAILS FUNCTIONAL TESTING WITH "SHORT CIRCUIT DETECTED" ERROR WHEN INSTALLED IN PORT A RECEPTACLE OF BOTH TEST DII AND COMPLAINT DII UNITS. NO EVIDENCE OF BURNT CONNECTOR PINS OR OVERHEATING WAS FOUND ON SAW. NO FURTHER TESTING IS POSSIBLE AFTER SAW FAILS FOR SHORT DETECTED ERROR. VENDOR INSPECTION: EVALUATION OF THE 7205786 SAGITTAL SAW, SERIAL NO. (B)(4), DETERMINED THAT THE HOUSING MOTOR SHAFT IS LOCKED. IN ADDITION, THE OUTPUT HEAD IS IMPROPERLY ALIGNED WITH THE MOTOR HOUSING. THIS APPEARS TO HAVE BEEN CAUSED BY AGE/WEAR, ALONG WITH A POSSIBLE MISHAP/IMPACT AT SOME POINT. (B)(4).

Description of Event or Problem · 1

DURING A FOOT/ANKLE PROCEDURE, THE CUSTOMER REPORTED THAT THE SAW/HANDPIECE GOT VERY HOT AND CAUSED A 3RD DEGREE BURN TO THE PATIENT'S LEG. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352924	DYONICS 25	DYONICS POWER SAGITTAL SAW	HAB	OKLAHOMA CITY MANUFACTURING SITE	7205786

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other