FDA Adverse Event Malfunction Summary report: N

2520274-2013-02819

MDR report key: 3130617 · Received May 24, 2013

Report

Report Number: 2520274-2013-02819
Event Type: Malfunction
Date Received: May 24, 2013
Date of Event: April 27, 2013
Report Date: April 27, 2013
Manufacturer: SYNTHES USA
Product Code: JDQ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES GMBH REPORTS AN EVENT IN (B)(4) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, THE SURGEON COULD NOT GET ZIPFIX TO STAY LOCKED. AFTER FIXING THE MANUBRIUM WITH A DOUBLE WIRE IN A FIGURE EIGHT CLOSURE, THE SURGEON INSERTED 5 ZIPFIX PERISTERNALLY. WHILE TENSIONING THE IMPLANTS, THE SECOND MOST DISTAL WOULD NOT STAY LOCKED. THE SURGEON TRIED SEVERAL TIMES AND WAS UNABLE TO GET IT TO STAY TENSIONED. THE SURGEON CLOSED WITH THE OTHER FOUR IMPLANTS AND LEFT THE PERISTERNAL SPACE EMPTY. THE SURGEON WAS SATISFIED THAT THE PATIENT HAD SUFFICIENT SUPPORT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
231655			JDQ	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1