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Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem No Code Available (3191)
Event Date 12/05/2016
Event Type  Injury  
Manufacturer Narrative
Review of the device history records show that the lot was released with no recorded anomaly or deviation. The warnings in the package insert state this type of event can occur. The user facility is foreign; therefore a facility medwatch report will not be available. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event Description
It is reported that "once all the plates were placed [the surgeon] was a little too excited to get things going and one of the tension band-plates-tensioners disengaged. " it is reported the procedure was completed with another band-plates-tensioner set. It is reported that there was no harm to the patient or "much of a delay. ".
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation.
Manufacturer Narrative
All four tensioners used were returned. Three of the tensioners have the thumb cam locked onto a band that has been sheared by the locking mechanism. These three also have the pull release fully retracted. These three are likely the tensioners that performed as intended. The fourth tensioner is likely the one that prematurely disengaged. The thumbcam is not locked indicating that the disengagement actually happened during initial approximation, before step 1. The band has been cut by some type of shear and the plate with the locking mechanism was not returned. The pull release appeared to be fully down (as assembled) but it was able to pushed down a small bit farther. This is likely was caused the tensioner to disengage from the locking mechanism. The pull release was likely bumped or accidently pulled just enough to allow the tensioner to become disengaged from the locking mechanism. The anti-rotational sleeve is what locks onto the locking mechanism. It is locked by the pull-release. Feature 1 on the anti-rotation sleeve was dimensionally evaluated with pin gages. It was measured in the open position with the pull release fully retracted and fell within specification. The complaint is that the tensioner prematurely disengaged from the locking mechanism. The complaint was confirmed as the tensioner was returned with a band that had not been sheared as intended. The most likely underlying cause of the complaint is the pull release being partially retracted allowing the tensioner to disengage with the locking mechanism. There are no indications of manufacturing defects.
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Manufacturer (Section D)
1520 tradeport drive
jacksonville FL 32218
Manufacturer (Section G)
1520 tradeport drive
jacksonville FL 32218
Manufacturer Contact
michelle cole
1520 tradeport drive
jacksonville, FL 32218
MDR Report Key6194233
Report Number0001032347-2016-00769
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2018
Device Model NumberN/A
Device Catalogue Number74-0004
Device Lot Number261710
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A
Patient Outcome(s) Required Intervention;