MAUDE Adverse Event Report: ZIMMER GMBH TWIST DRILL 25X95MM CANN 13MM STP 30MM

Model Number N/A

Device Problem Break (1069)

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

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer received the instrument, investigation is ongoing.X-rays or other source documents were not provided for review.Where lot numbers were received for the instrument, the instrument history records were reviewed and found to be conforming.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).

Event Description

It was reported that on (b)(6) 2016 the drill bit broke during drilling of a foot operation over a 1,1mm k-wire.No pieces were left in the patient's body and the surgery was completed with another instrument with 10 minutes delay.

Manufacturer Narrative

Investigation results were made available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.Review of event description: it was reported that the twist drill was broken while drilling of a foot operation over a 1,1mm k-wire.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: visual examination: the twist drill and a k-wire were returned for investigation.The visual examination shows that the twist drill was broken at the weakest point.The k-wire is stuck in the front of the twist drill and cannot be removed by hand.The k-wire is strongly bent.This is an indication that high load was applied to the devices during the surgery.The returned twist drill has been measured.According to product drawing all relevant criterias were according to specifications.No reference number was available for the k-wire.The outer diameter of the k-wire was measured as 1.10mm.The inner diameter of the twist drill was measured as 1.40mm, which is according specifications.No functional test could be performed as the device was broken and damaged.Root cause determination using rmw: breakage of instrument due to inadequate design for intended performance not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration, systematic assessment defined in complaint investigation or in the current pms process.Deterioration in function due to wrong maintenance.Not possible.The issue reported is not due to a maintenance issue.Malfunction, insufficient device performance or durability due to user´s disregard of manufacturer´s recommendation.Use error (slips,lapses, mistakes, reasonably foreseeable misuse).Abnormal use beyond risk control.Possible, the received devices were investigated.The visual investigation showed that the twist drill was broken at the weakest point in the middle section of the device.The k-wire is strongly bent which is an indication that the user applied high forces during the surgery.No further information was received about the surgical procedure and patient's bone condition.In conclusion it can be assumed that the twist drill was also bent together with the k-wire to one direction and finally broke at the weakest point due to high forces applied.Dysfunctionality / malfunction of defective device and instruments due to inadequate transportation condition, or wrong handling during transportation imposed by user and/or the environment not possible.As the device was in usage and should be checked before the surgery starts.Such damages would have been seen prior to the surgery.Dysfunctionality / malfunction of defective devices and instruments due to mishandling of device by user possible, the received devices were investigated.The visual investigation showed that the twist drill was broken at the weakest point in the middle section of the device.The k-wire is strongly bent which is an indication that the user applied high forces during the surgery.No further information was received about the surgical procedure and patient's bone condition.In conclusion it can be assumed that the twist drill was also bent together with the k-wire to one direction and finally broke at the weakest point due to high forces applied.Conclusion summary: it was reported that the twist drill was broken during the surgery by the time the user was drilling.The received devices were investigated.The visual investigation showed that the twist drill was broken at the weakest point in the middle section of the device.The k-wire is strongly bent which is an indication that the user applied high forces during the surgery.No further information was received about the surgical procedure and patient's bone condition.In conclusion it can be assumed that the twist drill was also bent together with the k-wire to one direction and finally broke at the weakest point due to high forces applied.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: TWIST DRILL 25X95MM CANN 13MM STP 30MM
• Type of Device: TWIST DRILL 25X95MM CANN 13MM STP 30MM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6197796
• MDR Text Key: 63060067
• Report Number: 0009613350-2016-01478
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 502015620
• Device Lot Number: 14806
• Other Device ID Number: 00889024111363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1