MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK 360 MULTI-IMPLANT SYSTEM

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.

• Brand Name: STERNALOCK 360 MULTI-IMPLANT SYSTEM
• Type of Device: MULTI-IMPLANT SYSTEM
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6194233
• MDR Text Key: 62978266
• Report Number: 0001032347-2016-00769
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK151019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• 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 Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 261710
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention