FDA Adverse Event Malfunction Summary report: N

EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE

MDR report key: 2060829 · Received March 11, 2011

Report

Report Number: 1221934-2011-00097
Event Type: Malfunction
Date Received: March 11, 2011
Date of Event: March 1, 2011
Report Date: March 1, 2011
Manufacturer: DEPUY MITEK
Product Code: HRX
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT DEVICE HAS NOT YET BEEN REC'D, HOWEVER, HISTORICALLY, THIS TYPE OF FAILURE HAS BEEN ATTRIBUTED TO THE POSSIBILITY THAT THE USER MAY HAVE HIT BONE OR SOME OTHER OBJECT WHEN DEPLOYING THE NEEDLE THROUGH THE SOFT TISSUE CAUSING THE DISTAL PORTION OF THE NEEDLE TO POSSIBLY FATIGUE AND BREAK OFF. ALSO, THIS IS A SINGLE USE DEVICE, AND IT WAS NOT ESTABLISHED THAT THE DEVICE WAS USED ONLY ONCE, WHICH COULD HAVE LED TO THIS PARTICULAR FAILURE MODE AS WELL. OUTSIDE OF THESE HYPOTHESES AND CONSIDERATION NO CONCLUSIONS CAN BE DRAWN. WHEN THE COMPLAINT DEVICE IS REC'D HERE AT DEPUY MITEK IT WILL BE SUBJECTED TO A ROOT CAUSE ANALYSIS. IF THE ANALYSIS IDENTIFIES ANY DEFINITIVE ROOT CAUSE A F/U REPORT WILL BE FILED. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED.

Description of Event or Problem · 1

OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIP OF AN EXPRESSEW SUTURE PASSER NEEDLE BROKE OFF INTO THE PT'S JOINT SPACE. THE FRAGMENT WAS NOT RETRIEVED FROM THE BODY, HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. (THIS HAPPENED IN 2 SEPARATE PROCEDURES ON THE SAME DAY; SEE ASSOCIATED MDR 1221934-2011-00096).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE	ARTHROSCOPIC INSTRUMENT	HRX	DEPUY MITEK	214005	A010022

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK