MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 S-ROM*EXTRACTOR STEM LOOP; HIP INSTRUMENT/TRIAL

Catalog Number 534400

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

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 srom extractor loop was broke at the loop during the extraction process.

Manufacturer Narrative

No instrument associated with this report was received for examination.Depuy considers the investigation closed.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 will be filed as appropriate.

Manufacturer Narrative

Product complaint # : (b)(4).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 will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).

• Type of Device: HIP INSTRUMENT/TRIAL
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 6862090
• MDR Text Key: 85995417
• Report Number: 1818910-2017-24538
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295171973
• UDI-Public: 10603295171973
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/14/2017

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: 534400
• Device Lot Number: A0908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 10/12/2017; 08/31/2018; 09/04/2018
• Supplement Dates FDA Received: 10/12/2017; 09/11/2018; 09/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2008
• 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