FDA Adverse Event Malfunction Summary report: N

BATTERY HANDPIECE/MODULAR FOR TRAUMA RECON SYSTEM

MDR report key: 3132535 · Received May 29, 2013

Report

Report Number: 8030965-2013-02394
Event Type: Malfunction
Date Received: May 29, 2013
Report Date: February 20, 2013
Manufacturer: SYNTHES GMBH
Product Code: GEY
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(6).

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

Additional Manufacturer Narrative · 1

THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTER'S COMPLAINT OF A STICKY TRIGGER WAS CONFIRMED. THE MODULAR BATTERY HANDPIECE WAS TESTED AND THE COMPLAINT WAS DUPLICATED. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME.

Description of Event or Problem · 1

IT WAS REPORTED, DURING A SURGICAL IN (B)(6) 2013, THE BATTERY HAND PIECE HAD A STICKY TRIGGER AND THE BATTERIES GOT WARM. IT WAS ALSO REPORTED THE PROCEDURE WAS DELAYED APPROXIMATELY ONE MINUTE, AND WHERE A BACKUP DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS REPORTED. THIS REPORT IS FOR BATTERY HANDPIECE/MODULAR FOR TRAUMA RECON SYSTEM. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
237514	BATTERY HANDPIECE/MODULAR FOR TRAUMA RECON SYSTEM		GEY	SYNTHES GMBH		2953

Patients

Seq	Age	Sex	Outcome	Treatment
1