MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 LPS INSERTER EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 298772030

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

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 instrument in question was not used on this case.The set was ordered as a backup to the attune revision which was actually used.The case went perfectly.The instrument set was checked and noticed the threaded portion of the lps stem extractor was bent.This instrument was returned to the office in the lps instrument tray so it can be replaced.

Manufacturer Narrative

Product complaint # : (b)(4).Examination of the returned instrument confirmed the reported observation.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.

• Brand Name: LPS INSERTER EXTRACTOR
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7506887
• MDR Text Key: 107998777
• Report Number: 1818910-2018-59403
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295159131
• UDI-Public: 10603295159131
• 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
• Report Date: 04/17/2018

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: 298772030
• Device Lot Number: SO2014879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2014
• 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
• Patient Age: 71 YR