FDA Adverse Event Injury Summary report: N

2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE

MDR report key: 4100915 · Received September 19, 2014

Report

Report Number: 1719045-2014-10454
Event Type: Injury
Date Received: September 19, 2014
Report Date: August 21, 2014
Manufacturer: SYNTHES MONUMENT
Product Code: HTO
PMA / PMN Number: PEXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: (B)(4) MANUFACTURED THE REAMING ROD WITH BALL TIP, PART NUMBER 351.706S AND LOT NUMBER 5872341. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE AND TO THE SYNTHES FINAL INSPECTION SHEET. ANALYSIS SHOWED THAT THE MATERIAL WAS ACCEPTABLE. 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 PATIENT HAD A HELICAL BLADE PLACED IN TREATMENT OF A HIP AND SHATTERED FEMUR. SINCE TREATMENT FROM ORTHOPEDIST AND RHEUMATOLOGIST, PATIENT EXPERIENCES SIGNS AND SYMPTOMS OF CONSTANT ACHE AND PAIN. IT WAS ALSO REPORTED THAT THE PATIENT IS CONCERNED THAT HE MAY POSSIBLY BE HAVING A TITANIUM REACTION. DOCTOR'S RECOMMENDATION IS A FULL HIP REPLACEMENT IF CONSTANT ACHE CONTINUES. TO DATE, NO EXPLANT IS SCHEDULED. THIS IS REPORT 4 OF 4 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
584140	2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE	REAMER	HTO	SYNTHES MONUMENT		5872341

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention