MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP DUOFIX TIB CENTRAL DRILL; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number 9505-02-034

Device Problems Dull, Blunt (2407); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the device was reviewed by depuy engineering (b)(4) root cause attributed to the device being worn from normal use and servicing.The photographs show the cutting edges of the duofix central drill are worn and blunt if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Hospital reported damaged instruments that need replacement.

• Brand Name: HP DUOFIX TIB CENTRAL DRILL
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10119067
• MDR Text Key: 194017231
• Report Number: 1818910-2020-13204
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10603295227533
• UDI-Public: 10603295227533
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9505-02-034
• Device Catalogue Number: 950502034
• Device Lot Number: NG1008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1