FDA Adverse Event Malfunction Summary report: N

12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

MDR report key: 3884695 · Received June 19, 2014

Report

Report Number: 1719045-2014-10269
Event Type: Malfunction
Date Received: June 19, 2014
Date of Event: May 23, 2014
Report Date: May 23, 2014
Manufacturer: SYNTHES MONUMENT
Product Code: HTO
PMA / PMN Number: PK111437
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ADDITIONAL CLASSIFICATION CODE HRX. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES TABULATED INCOMING FINAL INSPECTION SHEET # (B)(4), REVISION ¿(B)(4).¿ THERE WERE NO COMPLAINT-RELATED ISSUES, MANUFACTURING REPORT RECORDS, OR NON CONFORMANCE RECORDS ASSOCIATED WITH THIS LOT. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE. THE REAMER/IRRIGATOR/ASPIRATOR (RIA) WAS MANUFACTURED TO THE SYNTHES DRAWING NUMBER (B)(4), REVISION ¿(B)(4)¿, RELEASED ON (B)(4) 2009. 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 REAMER HEAD BROKE OFF INTO THE TIBIA DURING A TIBIAL NAIL PROCEDURE FOR A TIBIA FRACTURE. ALL OF THE PIECES OF THE DEVICE WERE RETRIEVED. THERE WAS NO DELAY IN SURGERY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER REAMER HEAD THAT WAS AVAILABLE. PATIENT STATUS WAS NOT REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
361605	12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR	REAMER	HTO	SYNTHES MONUMENT		7370635

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR