FDA Adverse Event Injury Summary report: N

PFNA-II BLADE L85 TAN

MDR report key: 2854859 · Received December 3, 2012

Report

Report Number: 2520274-2012-03519
Event Type: Injury
Date Received: December 3, 2012
Date of Event: July 30, 2009
Report Date: August 24, 2009
Manufacturer: SYNTHES
Product Code: HSB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

Description of Event or Problem · 1

(B)(6) COMPLAINT HANDLING UNIT REPORTED A BLADE PENETRATED THE FEMORAL HEAD. OPERATION OF TROCHANTERIC FRACTURE WAS ON THE (B)(6) 2009. POST-OPERATION, PATIENT FELT PAIN IN THE OPERATED AREA. THE BLADE PENETRATION WAS FOUND AND A REVISION OF THE BLADE WAS MADE ON THE (B)(6) 2009. THE NAIL WAS LEFT IN PLACE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PFNA-II BLADE L85 TAN	PFNA-II BLADE	HSB	SYNTHES

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention