MAUDE Adverse Event Report: ZIMMER INC MG II BONE SCREW DRILL BIT; HTW

Catalog Number 00512008500

Device Problems Break (1069); Fracture (1260); Device Issue (2379); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.(b)(4).Other device used: catalog #00599707600, nexgen tibial cut guide, lot #73224200.This report will be amended when our investigation is complete.(b)(4).

Event Description

It is reported that, when drilling into the tibia, the drill became stuck and snapped upon removal.Upon examining the cutting guide, it was determined that a small burr in a few of the drill guide holes was causing drill bits to become stuck in the cutting block.

Manufacturer Narrative

Instrument was manufactured on march 28, 2013; pre-udi requirement.The drill bit and cut guide were both returned for review.Visual inspection revealed that the drill fracture near the distal end.Nicks and gouging are also observed along the shaft and the flutes.Visual inspection of the guide confirms gouging and burrs within the drill guide holes.Dimensions were found conforming to print specifications where measured.Hardness testing of both components confirms the hardness was within specification.Device history records were reviewed on this product lot and identified no deviations or anomalies.This type of event was previously investigated through zimmer work instructions (zwi).These devices are used for treatment.A product history search revealed no additional complaints against the related drill and cut guide part and lot combinations.The drill was manufactured on 28 mar 2012 and the cut guide was manufactured on 27 apr 2001, having been in the field almost 4 years and 15.5 years respectively.It is unknown how many times the devices had been used during that time.It is likely that the observed burrs were from normal usage and wear during the instruments field life.The seizing likely occurred due to the observed burrs and in an attempt to remove, likely resulted in the observed drill fracture.

• Brand Name: MG II BONE SCREW DRILL BIT
• Type of Device: HTW
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 5494973
• MDR Text Key: 40338377
• Report Number: 1822565-2016-00676
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00512008500
• Device Lot Number: 62038460
• Other Device ID Number: SEE NARRATIVE IN H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2012
• 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 Age: 78 YR