MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. LPS INSERTER EXTRACTOR; LPS IMPLANT

Catalog Number 298772030

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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

During impaction the inserter broke, after the inserter broke there was only one way for doctor to remove handle which was by hitting the version control piece which broke also.

Manufacturer Narrative

The devices associated with this report were not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product lot codes required were not provided.A two-year search of the complaint database against the provided product codes was conducted and no trends were identified.The root cause of the reported lps inserter version control breakage is attributed to hitting the device while removing the lps inserter extractor.The investigation could not draw any conclusions about the root cause of the reported inserter extractor breakage without the device to examine.Based on the inability to determine a root cause for the broken lps inserter extractor and the root cause of the broken lps inserter version control being secondary to the extractor breakage, a need for corrective action is not indicated.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.

Manufacturer Narrative

Udi: (b)(4).Update december 6, 2016: received complaint sample devices for evaluation: examination of the submitted device confirmed the reported breakage.The root cause is attributed to misuse.Based on the root cause determination of misuse, the need for corrective action is not indicated.Monitor complaints through sep-419.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: LPS INSERTER EXTRACTOR
• Type of Device: LPS IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6051424
• MDR Text Key: 58192682
• Report Number: 1818910-2016-30034
• Device Sequence Number: 1
• Product Code: HWB
• 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
• Report Date: 10/21/2016

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: A0211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 10/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/17/2016; 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2011
• 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: 69 YR