PASSING PINS & GUIDE

MDR report key: 2884715 · Received December 25, 2012

Report

Report Number: 1219602-2012-00354
Event Type: Malfunction
Date Received: December 25, 2012
Date of Event: November 26, 2012
Report Date: November 26, 2012
Manufacturer: MANSFIELD MANUFACTURING SITE
Product Code: HWE
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

Additional Manufacturer Narrative · 1

ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS FORWARDED TO THE SUPPLIER FOR ANALYSIS. THE SUPPLIER NOTED DURING VISUAL INSPECTION THAT THE TIP OF THE PASSING PIN WAS TWISTED AND PART WAS BROKEN ALMOST IN HALF, IT APPEARS TO HAVE BEEN EITHER USED INCORRECTLY OR EXCESSIVE FORCE WAS APPLIED. IT WAS CONFIRMED BY THE SUPPLIER THAT THE DEVICE WAS MANUFACTURED TO AND MET PRINT SPECIFICATION. THE DHR RECORDS WERE REVIEWED AND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURE OF THE DEVICE. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. NO FURTHER ACTION IS WARRANTED AT THIS TIME. (B)(4).

Description of Event or Problem · 1

DURING A KNEE LIGAMENTOPLASTY, THE SURGEON WAS USING A DRILL TIP PASSING PIN 2.4 X 381 MM, INTRA-OPERATIVE THE PASSING PIN BROKE. AN INCISION WAS NEEDED TO REMOVE THE BROKEN PIECE AND THE SURGERY WAS EXTENDED APPROXIMATELY 40 MINUTES. A BACK UP DEVICE WAS ON HAND TO COMPLETE THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PASSING PINS & GUIDE	PIN,PASSING,DRILL TIP	HWE	MANSFIELD MANUFACTURING SITE	7208678	50436913

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention