FDA Adverse Event Malfunction Summary report: N

CLAVICLE PIN ASSEMBLY 2.5MM

MDR report key: 1840035 · Received September 15, 2010

Report

Report Number: 1818910-2010-06303
Event Type: Malfunction
Date Received: September 15, 2010
Report Date: August 18, 2010
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: JDW
PMA / PMN Number: K991649
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EXAMINATION OF THE RETURNED PRODUCT BY A DEPUY (B)(4) MATERIAL RESEARCH SCIENTIST CONFIRMED THE FRACTURE. A TORSIONAL LOAD WAS APPLIED THAT EXCEEDED THE MATERIAL STRENGTH OF THE COMPONENT LEADING TO TORSIONAL OVERLOAD FAILURE. NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS WAS OBSERVED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. REVIEW OF THE DEVICE HISTORY RECORDS AND INSPECTION RECORDS FOUND NO MANUFACTURING DEVIATIONS OR REJECTIONS. A PREVIOUS INVESTIGATION FOUND PRODUCT DEVELOPMENT, MARKETING, AND SURGEON INPUT HAS DETERMINED THAT THE 2.5 MM PIN NEEDS TO HAVE A SHORT VERSION FOR SMALL PTS TO HELP PREVENT BREAKAGES. (B)(4) WAS INITIATED ON JULY 28TH, 2009 TO ADDRESS THE CORRECTIVE ACTIONS. NO FURTHER ACTION WAS TAKEN. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

Description of Event or Problem · 1

INTRAOPERATIVELY THE PIN BROKE TWICE. ONE FRAGMENT REMAINED IN PT'S CLAVICLE. IT WILL NOT BE REMOVED AS THIS WOULD BE TOO COMPLEX. SURGERY PROLONGATION ABOUT 20 MINUTES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CLAVICLE PIN ASSEMBLY 2.5MM	87JDW	JDW	DEPUY ORTHOPAEDICS, INC.	NA	CK6CS1000

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA		Required Intervention