MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 GLENOID CANNULATED STOP DRILL; DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES

Catalog Number 230789000

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

Standard glenoid stop drill appears to be blunt and not penetrating bone as it should.No interruption to procedure.

Manufacturer Narrative

(b)(4).Investigation summary: it should be noted no device was returned hence the failure mode cannot be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: GLENOID CANNULATED STOP DRILL
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cede 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8197327
• MDR Text Key: 131431256
• Report Number: 1818910-2018-79156
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295116509
• UDI-Public: 10603295116509
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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: 230789000
• Device Lot Number: 6000000813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1