MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PROPHECY(R) INBONE(R) PATIENT SPECIFIC GUIDES; SMALL JOINT COMPONENT

Catalog Number PROPINB

Device Problem Fitting Problem (2183)

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

Event Date 03/19/2015

Event Type  Injury  

Event Description

Allegedly, the guides fit was less than ideal for the patient bone.He felt confident that he cleaned tissue from the talar neck without removing bone/osteophytes, and that there was minimal cartilage present on the dome.He ended up positioning the block against the dome and leaving a gap on the neck, which produced an acceptable cut.Issue was resolved by surgeon manipulating guides and completed case.The surgery time was extended by more 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(R) INBONE(R) 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: 4649033
• MDR Text Key: 5596271
• Report Number: 1043534-2015-00014
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K110360
• 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: 04/01/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PROPINB
• Device Lot Number: 1558537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR