FDA Adverse Event Malfunction Summary report: N

MULTILOC HN Ø8.5 LE CANN L270 TAN

MDR report key: 3133197 · Received May 29, 2013

Report

Report Number: 8030965-2013-02374
Event Type: Malfunction
Date Received: May 29, 2013
Date of Event: April 28, 2013
Report Date: April 29, 2013
Manufacturer: SYNTHES GMBH
Product Code: HSB
PMA / PMN Number: K120807
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: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

Additional Manufacturer Narrative · 1

ADDITIONAL EVALUATION COORDINATED BY SYNTHES (B)(4) REPORTS THE FOLLOWING: THE INVESTIGATION CONFIRMED THAT THE NAIL INTERFACE WAS BADLY DAMAGED. IT WAS REASONABLY SUGGESTED, BUT COULD NOT BE CONFIRMED; THAT TOO MUCH MECHANICAL FORCE OR AN INAPPROPRIATE CONNECTION BETWEEN THE NAIL AND THE INSERTION HANDLE MAY HAVE CAUSED THE DAMAGE TO THE DEVICE. FURTHER, THE DEVICE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORDS (DHR) WAS REVIEWED. NO ABNORMAL FINDINGS WERE IDENTIFIED.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(4) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, WHILE INSERTING THE NAIL WITH ROTATING MOVEMENT, THE TIP OF THE NAIL BROKE AND BECAME DAMAGED. REPORTEDLY THE NAIL INTERFERES WITH THE CORRECT NAIL INSERTION AND POSITION. THE NAIL WAS REPLACED WITH A NEW NAIL. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
234971	MULTILOC HN Ø8.5 LE CANN L270 TAN		HSB	SYNTHES GMBH		5917679

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR