MAUDE Adverse Event Report: ZIMMER GMBH TWO-FLUTED DRILL BIT 2.5

Catalog Number 103.25.180

Device Problems Fracture (1260); Unintended Collision (1429)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/09/2015

Event Type  Other  

Event Description

It was reported that during a surgery (exact date unknown), the instrument two-fluted drill bit 2.5 fractured because it interfered with k-wire.It was reported that the tip of drill was left into the tibia of the patient.

Manufacturer Narrative

The manufacturer did not receive the device for investigation.No surgical report or x-rays were provided for review.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Manufacturer Narrative

As soon as additional information become available and an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

Event Description

It was now reported that it was reported that during a surgery on (b)(6) 2015, the instrument two-fluted drill bit 2.5 fractured because it interfered with k-wire.It was reported that the tip of drill was left into the tibia of the patient.

Manufacturer Narrative

Dhr review: dhr records were reviewed and found to be conforming.Trend analysis: no trend identified.Compatibility check: the compatibility check could not be performed as only one product was reported to us.Event review: it was reported that the drill bit fractured during surgery due to impact against a k wire and that the broken fragment was left in the patient.Visual examination: the drill bit is broken and a piece was left in the patient.The fracture indicates an overload fracture.Possible causes for the reported event: drilling bit fractured and remained in the patient due to excessive deterioration of instruments during long term use, possible as it is not possible to determine the term of use.Drilling bit fractured and remained in the patient due to surgeon or staff unfamiliar with implantation technique.Possible as no information about the familiarity of the surgeon/op staff was provided.Drilling bit fractured and remained in the patient due to deterioration of cutting edges.Possible as only one part of the drill bit was returned for investigation and no information on the other part available.Drilling bit fractured and remained in the patient: due to impaction /torque force on instrument during operation; due to damage of instrument through incorrect use; due to off-label use; due to wrong handling.Possible as no information about the procedure followed was provided.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: TWO-FLUTED DRILL BIT 2.5
• Type of Device: TWO-FLUTED DRILL BIT
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4959909
• MDR Text Key: 6251013
• Report Number: 9613350-2015-00919
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 103.25.180
• Device Lot Number: 411684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other