MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC POLY EXTRACTOR; EXTRACTION INSTRUMENTS

Catalog Number 224414000

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the duraloc poly extractor broke.

Manufacturer Narrative

(b)(4).The reported observation could not be confirmed.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DURALOC POLY EXTRACTOR
• Type of Device: EXTRACTION INSTRUMENTS
• 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 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380 ; 6103142063
• MDR Report Key: 7250821
• MDR Text Key: 99319162
• Report Number: 1818910-2018-53030
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295107491
• UDI-Public: 10603295107491
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 224414000
• Device Lot Number: HT0508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 11/26/2018
• Supplement Dates FDA Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2008
• 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