MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. DARCO(R) PIA PLATE 6MM SPACER; SMALL JOINT COMPONENT

Catalog Number DCS2802006

Device Problems Material Discolored (1170); Nonstandard Device (1420)

Patient Problem No Information (3190)

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

Risk assessment ((b)(4)) was performed for this incident.This part/lot number was not distributed in the us.This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.

Event Description

The sterilization indicator on the box is the incorrect color.

Manufacturer Narrative

The scope of the items in the recall expanded to add the following: part number 4833104, lot number 1558414; part number 58s03538, lot number 1568030; part number 86sr0410, lot number 1564697; part number 200011901, lot number 1540433; part number 4151150045, lot number 1547961; part number d1s40032s, lot number 1555125; part number 777s06514, lot number 1555781; part number 58s30010, lot number 1556150; part number 4700001, lot number 1555726; part number 4700002, lot number 1574468; part number 4520002, lot number 1536734; part number dcs2805001, lot number 1552873.

• Brand Name: DARCO(R) PIA PLATE 6MM SPACER
• Type of Device: SMALL JOINT COMPONENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 901451-631
• MDR Report Key: 5916064
• MDR Text Key: 54282949
• Report Number: 1043534-2016-00094
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

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: Other
• Device Catalogue Number: DCS2802006
• Device Lot Number: 1555427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/19/2016
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1