FDA Adverse Event Injury Summary report: N

10MM/130 DEG TI CANN TFNA 170MM - STERILE

MDR report key: 5289445 · Received December 11, 2015

Report

Report Number: 1719045-2015-10817
Event Type: Injury
Date Received: December 11, 2015
Report Date: November 22, 2015
Manufacturer: SYNTHES MONUMENT
Product Code: HSB
PMA / PMN Number: PK131548
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW ¿ A REVIEW OF DEPUY SYNTHES (B)(4) DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO ISSUES. PART NUMBER: 04.037.042S. LOT NUMBER: 9800768. RAW MATERIAL NUMBER: 7775460. MANUFACTURE DATE: 05/12/15. EXPIRATION DATE: 2025-04-30. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION SURGERY OF A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) OCCURRED ON (B)(6) 2015. THE PATIENT HAD A NON-UNION AT THE AREA OF THE NAIL BREAKAGE. THE NAIL BROKE AT THE HELICAL BLADE HOLE IN THE NAIL. ALL HARDWARE AND FRAGMENTS OF THE NAIL WERE SUCCESSFULLY REMOVED. IT WAS NOTED THAT THE FRAGMENTS WERE DIFFICULT TO REMOVE, HOWEVER, THERE WAS NO SURGICAL DELAY REPORTED. THE NAIL WAS ORIGINALLY IMPLANTED ON (B)(6) 2015. THE PATIENT WAS REVISED TO A TOTAL HIP IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
819793	10MM/130 DEG TI CANN TFNA 170MM - STERILE	ROD,FIXATION,INTRAMEDULLARY	HSB	SYNTHES MONUMENT		9800768

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	TFNA HELICAL BLADE 110MM STERILE