MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. ORTHOLOC® 3DI PLATING SYSTEM-DEPTH GAUGE; SMALL JOINT COMPONENT

Catalog Number 59250100

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation not complete.Information pertaining to the delay in surgery was received 08/19/2015.Product has been returned.Trends will be evaluated.This report will be updated when the investigation is complete.

Event Description

Allegedly, the depth gauge readings resulted in the use of screws that were longer than desired.Had to swap out screws with shorter screws, which delayed surgery approximately 30 minutes.

Manufacturer Narrative

Dimensional inspection of the depth gauge shows that the reading on the scale shows 70 mm.Based on analysis, a definitive root cause could not be determined.

• Brand Name: ORTHOLOC® 3DI PLATING SYSTEM-DEPTH GAUGE
• 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 ; 901867-414
• MDR Report Key: 5082481
• MDR Text Key: 25997336
• Report Number: 1043534-2015-00067
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 59250100
• Device Lot Number: 1294428
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other