MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PROPHECY® PATIENT SPECIFIC GUIDES; SMALL JOINT COMPONENT

Catalog Number PROPINF

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Code Available (3191)

Event Date 03/25/2015

Event Type  Injury  

Event Description

Allegedly, the surgeon was unhappy with the pairing of instrument blocks to patient's bone.Implantation site/procedure: ankle.The case was finished, but blocks were a struggle and caused an extension in surgery greater than 30 minutes.

Manufacturer Narrative

Investigation not complete.Product has not been returned.Trends will be evaluated.This report will be updated when the investigation is complete.

• Brand Name: PROPHECY® PATIENT SPECIFIC GUIDES
• 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: 4796523
• MDR Text Key: 5882948
• Report Number: 1043534-2015-00032
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K131283
• 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: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROPINF
• Device Lot Number: 1558759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 05/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other