MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. G-FORCE(TM) HEX DRIVER; SMALL JOINT INSTRUMENT

Catalog Number 86PS-3016

Device Problem Sticking (1597)

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

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 1043534-2016-00088.

Event Description

Allegedly, when bringing in the implants, the screw driver would not release from the implant.The implant had to be pulled out with the screw driver.No delay was caused.

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: G-FORCE(TM) HEX DRIVER
• Type of Device: SMALL JOINT INSTRUMENT
• 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: 5900858
• MDR Text Key: 53842505
• Report Number: 1043534-2016-00087
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 86PS-3016
• Device Lot Number: 692771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/17/2016
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1