MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. TISSUE SPARING FEM CORE CASE 1; HIP INSTRUMENT/TRIAL

Catalog Number 259807390

Device Problems Flaked (1246); Peeled/Delaminated (1454); Delamination (2904)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).Followup with the complainant has been conducted for the lot number, and the information is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Plastic coating is peeling off of instrument holders in bottom of pans.It is also flaking off in some areas.

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 lot codes required were not provided.Based on the inability to identify root cause, the need for corrective action was 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.Depuy still 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: TISSUE SPARING FEM CORE CASE 1
• Type of Device: HIP INSTRUMENT/TRIAL
• 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: 5781646
• MDR Text Key: 49123719
• Report Number: 1818910-2016-22855
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 259807390
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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