FDA Adverse Event Malfunction Summary report: N

SYNREAM REAMER HEAD Ø18

MDR report key: 2851086 · Received November 29, 2012

Report

Report Number: 8030965-2012-01400
Event Type: Malfunction
Date Received: November 29, 2012
Report Date: October 31, 2012
Manufacturer: SYNTHES GMBH
Product Code: HTO
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE VISIBLE TRACES CAN BE EASILY REMOVED. THEREFORE WE CAN DEFINE, THAT THIS IS AN ACCRETION OF CONTACT CORROSION. ACCORDING OF CORROSION CAN BE GENERALLY SAID, THAT ALL MATERIALS ALSO SO CALLED STAINLESS STELLS ARE CONDITIONALLY RESISTANT TO RUST. THE RUST RESISTANT APPLIES ONLY IF THE MATERIAL IS STORED DRY AND IS FREE OF CONTACT WITH OTHER METAL OBJECTS. ALL METALLIC CONTACTS IN DAMP OR WET CONDITIONS PRODUCE ELECTROLYTIC REACTIONS WITH CONTACT CORROSION AS RESULT. THAT IS NORMAL WEAR AND TEAR. NO PRODUCT FAULT COULD BE DETECTED.

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

Description of Event or Problem · 1

A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: IT WAS FOUND ALL THEIR SYNREAM REAMER HEADS HAD TRACES OF CORROSION ON THEM. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 3 OF 22 REPORTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNREAM REAMER HEAD Ø18	REAMER HEAD	HTO	SYNTHES GMBH		20504

Patients

Seq	Age	Sex	Outcome	Treatment
1