MAUDE Adverse Event Report: ZIMMER INC BIGLIANI/FLATOW THUMB SCREW; KWT

Catalog Number 00430100201

Device Problems Fracture (1260); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/18/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product was returned with complaint for review.Photo and visual exams confirmed the humeral inserter/extractor thumb screw was fractured approximately 2 inches from the knurled knob.The screw was noted returned with approximately.280" of the threaded feature fractured and missing.Print specifications were reviewed and micrometers testing was performed.The shaft diameter and material hardness were conforming to specifications.It was reported the surgeon used a mallet to tap on the instrument to remove the humeral stem.This is not the recommended method for removing a stem as described in the bigliani/ flatow surgical technique, which states to use a stem extractor attached to the humeral inserter/ extractor for removal.Using the humeral inserter/ extractor by itself may have exposed the screw to greater than anticipated forces.The device is used for treatment.This issue has been investigated and a product history search indicated no other complaints of any type have been reported for this lot.Based on its lot number, the screw has an approximate field age of 7 years.User error appears to be a contributing factor to this event.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

During surgery, when the surgeon was removing a humeral stem, he was trying to tap out the implant because it did not fully seat.While the surgeon was tapping out with a mallet, it was noted the bolt snapped at the tip.The attending distributor reported: it is believed the tip on the bolt was left in the implant as it broke on the threads; it would have been very hard to get the fractured piece out of the implant.

• Brand Name: BIGLIANI/FLATOW THUMB SCREW
• Type of Device: KWT
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer (Section G): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• MDR Report Key: 5571971
• MDR Text Key: 42489668
• Report Number: 1822565-2016-01050
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00430100201
• Device Lot Number: 60683359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other