MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. VALOR(R) SCREW; SMALL JOINT COMPONENT

Catalog Number 4151150035

Device Problems Difficult to Insert (1316); Mechanical Jam (2983)

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

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

This investigation is not complete.This report will be updated when the investigation is complete.The surgery time was extended.This is the same event as 1043534-2016-00028 and 1043534-2016-00038.

Event Description

It was reported that the compression screw got jammed inside the implant.Compression could not be achieved and the posterior screw could not be inserted.In the end they could remove the compression screw and a new implant was used.

Manufacturer Narrative

This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.

• Brand Name: VALOR(R) SCREW
• 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: 5721128
• MDR Text Key: 48414484
• Report Number: 1043534-2016-00039
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K090857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

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: Other
• Device Catalogue Number: 4151150035
• Device Lot Number: 1557910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 06/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR