MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® RESECTION ADJUSTMENT BLOCK; SMALL JOINT COMPONENT

Catalog Number 33600030

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation is not yet complete.Trends will be evaluated.This report will be updated when the investigation is complete.

Event Description

Allegedly, it was reported that the resection adjustment block completely seized when the surgeon tried to turn the knobs.No back-up device -- freehand positioning.

• Brand Name: INFINITY® RESECTION ADJUSTMENT BLOCK
• Type of Device: SMALL JOINT COMPONENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: monica burt ; 1023 cherry road; memphis, TN 38117 ; 901290-566
• MDR Report Key: 5607926
• MDR Text Key: 44449310
• Report Number: 1043534-2016-00024
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2016

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: 33600030
• Device Lot Number: 1434693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 04/26/2016
• 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: N
• Patient Sequence Number: 1