FDA Adverse Event Injury Summary report: N

RAPIDLOK MENISCAL FASTENER

MDR report key: 1212570 · Received October 24, 2008

Report

Report Number: 1221934-2008-00491
Event Type: Injury
Date Received: October 24, 2008
Date of Event: October 8, 2008
Report Date: October 13, 2008
Manufacturer: DEPUY MITEK
Product Code: MBI
Removal / Correction Number: UNK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: EI
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

MITEK IS AT THIS POINT IN TIME AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING A FAILURE ANALYSIS. WE ARE ALSO ENGAGED IN THE PROCESSES OF THE INFORMATION GATHERING. WHEN ALL THAT CAN BE HAD, IS HAD AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT OF THE FOLLOW UP REPORT.

Description of Event or Problem · 1

OUR AFFILIATE IS REPORTING THAT DURING AN ARTHROSCOPIC KNEE REPAIR, 5 MENISCAL FASTENERS DEPLOYED CORRECTLY, HOWEVER, THEIR SUTURES FAILED TO HOLD; PART # 228310, 1 EACH FROM LOTS 0710083 & 3177778 AND 3 FROM LOT 3154987. IT IS REPORTED THAT THE SUTURES ON ALL 5 DEVICES BROKE OR WAS INADVERTENTLY CUT AFTER SNOGGING THE KNOT DOWN FOR FIXATION, THIS RESULTED IN ALL 5 DEVICES FALLING INTO THE PATIENT'S KNEE JOINT. AT THIS POINT IN TIME, IN ORDER TO REMOVE THE RAPIDLOC DEVICES AND TO REPAIR THE MENISCUS, THE SURGEON CHOSE TO PERFORM A MENISECTOMY FOR REMEDY. ALL OF THE "TOP HAT" PORTIONS OF THE RAPIDLOCKS WERE REMOVED FROM THE BODY, HOWEVER, THE "BACK STOP" PORTION OF THE DEVICES WERE NOT ABLE TO BE RETRIEVED AND REMAIN IN THE JOINT SPACE. THIS PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. ALSO SEE ASSOCIATED MDRS 1221934-2008-00490, 00492, 00493 AND 00494.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RAPIDLOK MENISCAL FASTENER	SOFT TISSUE FIXATION DEVICE	MBI	DEPUY MITEK	228310	3154987

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK