MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MODULAR HEAD BALL REMOVER; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 212500600

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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

Hammerplate breakes from handle ( 2 pieces), broken tip, broken drill attachment.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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.

• Brand Name: MODULAR HEAD BALL REMOVER
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8175963
• MDR Text Key: 130793195
• Report Number: 1818910-2018-78569
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295087878
• UDI-Public: 10603295087878
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2018

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: 212500600
• Device Lot Number: AG2004039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/05/2018; 12/27/2018
• Supplement Dates FDA Received: 01/03/2019; 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2012
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1