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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BLACK MAMBA SUTURE PASSER

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ZIMMER BIOMET, INC. BLACK MAMBA SUTURE PASSER Back to Search Results
Model Number N/A
Device Problems Difficult or Delayed Positioning (1157); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/13/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(6).The instrument was not returned for evaluation due to being discarded.The product that exhibited the failure mode was reproduced using needles and a silicone membrane to substitute as the tissue.By using this set up the, fracture was recreated in the same location.Further investigation of the needle did not reveal any dimensional problems or manufacturing defects for the needle.Analysis of the passer showed that needle track was biased to far to one side.This would allow the needle to come out of it's track and twist.This increased the resistance or force required to "push" the needle through the tissue.This further supports the evidence that the needle is under high compression causing the needle to buckle/break.Review of the dhr found units were released for distribution with no deviation or anomaly.Review of complaint history identified associated complaint and a trend which was addressed through internal controls.The root cause was determined to be associated with failure during design verification, failure to implement appropriate inspection techniques, and incorrect prints from vendor.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports:09985.
 
Event Description
It was reported that patient underwent a rotator cuff repair procedure on (b)(6) 2014 utilizing a suture passer.During the procedure, the nitinol needle fractured inside the mamba suture passer.A bipass suture passer was used to complete the procedure without significant delay.There was no injury to the patient as a result.
 
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Brand Name
BLACK MAMBA SUTURE PASSER
Type of Device
PASSER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7007517
MDR Text Key92212545
Report Number0001825034-2017-09986
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number110010849
Device Lot Number169620
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/13/2014
Initial Date FDA Received11/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Age64 YR
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