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U.S. Department of Health and Human Services

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

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ZIMMER GMBH TWIST DRILL 25X95MM CANN 13MM STP 30MM Back to Search Results
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).
 
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Brand NameTWIST DRILL 25X95MM CANN 13MM STP 30MM
Type of DeviceTWIST 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 Key6197796
MDR Text Key63060067
Report Number0009613350-2016-01478
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number502015620
Device Lot Number14806
Other Device ID Number00889024111363
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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