FDA Adverse Event Malfunction Summary report: N

QUICKSET TPRD HEX SCDR U-JOINT

MDR report key: 3168129 · Received June 13, 2013

Report

Report Number: 1818910-2013-18820
Event Type: Malfunction
Date Received: June 13, 2013
Date of Event: June 12, 2013
Report Date: June 12, 2013
Manufacturer: 1818910 DEPUY ORTHOPAEDICS, INC.
Product Code: LXH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PREVIOUS INVESTIGATIONS FOUND THE ROOT CAUSE IS ATTRIBUTED TO THE SUPPLIER¿S HEAT TREATING PROCESS; CORROSION FOUND WITH CARBIDE EMBRITTLEMENT AS A POSSIBLE CONTRIBUTING FACTOR. IMPROVEMENTS TO THE HEAT TREATING PROCESS HAVE BEEN RECOGNIZED AND A SUPPLIER CHANGE REQUEST TO HEAT TREAT ALL 400 SERIES STAINLESS STEEL COMPONENTS IN THE UNITED STATES HAS BEEN IMPLEMENTED AND RELEASED. SCR-002557 RELEASED (B)(4) 2012, TO REQUEST THE USE OF AN ALREADY APPROVED HEAT TREAT SUPPLIER, (B)(4). MONITOR THROUGH TREND ANALYSIS. IT IS UNKNOWN IF THE COMPLAINT SAMPLE WAS MANUFACTURED PRIOR OR AFTER THE CHANGE SINCE THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER WERE NOT PROVIDED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Description of Event or Problem · 1

SCREWDRIVER TIP BROKE OFF WHILE SCREWING IN CUP SCREW. FOUND ONE LARGE PIECE, BUT DID NOT LOCATE SMALLER PIECE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
269495	QUICKSET TPRD HEX SCDR U-JOINT	HIP INSTRUMENT	LXH	1818910 DEPUY ORTHOPAEDICS, INC.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Required Intervention