FDA Adverse Event Malfunction Summary report: N

INLINE HANDLE WITH QUICK RELEASE AND SPORT GRIP

MDR report key: 3022264 · Received March 26, 2013

Report

Report Number: 1719045-2013-00731
Event Type: Malfunction
Date Received: March 26, 2013
Report Date: February 27, 2013
Manufacturer: SYNTHES MONUMENT
Product Code: LXH
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THIS REPORT IS PART OF THE SERVICE AND REPAIR DOCUMENTATION REMEDIATION. DEVICES THAT WERE RECEIVED BY SERVICE AND REPAIR HAVE EITHER BEEN REPAIRED AND RETURNED TO THE CUSTOMER OR DISCARDED BY SYNTHES, MAKING FURTHER PRODUCT EVALUATION BY MANUFACTURING OR ENGINEERING IMPOSSIBLE. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. UPDATED INFORMATION, NORMAL WARRANTY ITEMS AND NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RETURNED BECAUSE THERE WAS A SEPARATION OF A COMPONENT, THE TIP WAS PULLING OFF. THE PRODUCT WAS RECEIVED AT SERVICE AND REPAIR WHO WERE UNABLE TO REPAIR THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ANY OTHER INFORMATION IS RECEIVED, IT WILL BE REPORTED VIA A SUPPLEMENT.

Description of Event or Problem · 1

IT IS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, A HANDLE FOR HOOK OR SCREW HOLDER WAS CHIPPED AND TWO INLINE HANDLES HAD THE TIPS PULLING OFF WHEN REMOVING THE TRIALS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR TWO INLINE HANDLES FROM THE SAME LOT. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
124185	INLINE HANDLE WITH QUICK RELEASE AND SPORT GRIP		LXH	SYNTHES MONUMENT		5615328

Patients

Seq	Age	Sex	Outcome	Treatment
1