FDA Adverse Event Malfunction Summary report: N

SPAREREAMERTUBE F/309.065

MDR report key: 3092506 · Received May 3, 2013

Report

Report Number: 8030965-2013-02114
Event Type: Malfunction
Date Received: May 3, 2013
Report Date: April 9, 2013
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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

Additional Manufacturer Narrative · 1

THE INVESTIGATION HAS SHOWN THAT THE ITEM IS BROKEN OFF AT THE TIP. THE SPARE REAMER TUBE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS, AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE BROKEN SURFACES ARE HOMOGENOUS WHICH INDICATE MATERIAL CONFORMITY TO THE SPECIFICATIONS AS WELL. BASED ON THESE FINDINGS WE HAVE TO ASSUME THAT THE REAMER CAME IN CONTACT WITH A METALLIC PART, WHICH FINALLY CAUSED THE BREAKAGE. OR SIMPLY TOO MUCH MECHANICAL FORCE HAD TO BE APPLIED IN ORDER TO REMOVE THE SCREW.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, A HOLLOW REAMER BROKE DURING SCREW REMOVAL. IT IS UNKNOWN IF ALL THE PIECES WERE RETRIEVED FROM THE PATIENT. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
193711	SPAREREAMERTUBE F/309.065		HTO	SYNTHES GMBH		2137764

Patients

Seq	Age	Sex	Outcome	Treatment
1