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U.S. Department of Health and Human Services


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Catalog Number 0115311
Device Problems Material Frayed (1262); Difficult To Position (1467); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2017
Event Type  malfunction  
Manufacturer Narrative
The device in question is being returned to davol for evaluation. The sample has not been received at this time. If / when the sample is returned and an evaluation has been completed a supplemental mdr will be submitted to document the results. Currently it is unknown why the user had difficulty in placing the device. If a malfunction of this nature were to recur it is not expected that a user would choose to prolong the case for such an extended period of time (1-2 hours) before attempting to use an alternative device. The recurrence of the reported malfunction/condition may in some cases prevent the device from being used, however the process of switching to alternative device if needed is anticipated to result in only an inconsequential delay, while the device is being exchanged for another. As was identified in the reported complaint the switch out to the alternative device took approximately 3 minutes. The likelihood that another user would prolong the case for such a long period as was reported is considered to be remote. Therefore it is not anticipated that the recurrence of a malfunction of this nature is likely to cause or contribute to death or serious injury upon recurrence. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The patient information could not be obtained due to the personal information protection law in (b)(6).
Event Description
It was reported that during a laparoscopic hernia repair procedure, the bard 3dmax mesh could "not be used smoothly. " as reported the user attempted to place the mesh in the correct anatomical location to facilitate repair for an extended period of time (1-2 hours). After being unsuccessful in placing the device the surgeon removed the mesh from the site and used another 3dmax mesh that was on hand and completed the procedure in 3 minutes time. The mesh had not been fixated and there was with no change in surgical approach and remained a laparoscopic procedure. The event did not result in patient injury, or necessitate surgical intervention as the mesh was removed from the site without issue and another placed. As reported the extension of surgery time did not result in any adverse patient outcome. The surgeon is reported to be an experienced user of the product having used it for more than 3-years. As reported, there was nothing abnormal about the patient anatomy that contributed to the difficulty.
Manufacturer Narrative
This is an addendum to the initial mdr to document the results of the manufacturing review and sample evaluation. A review of the manufacturing records was performed and found that the lot was manufactured to specification. A review of the ifu instructs the user to use an appropriate sized trocar to allow the mesh to slide down the trocar with minimal force. In the event the mesh will not easily deploy down the trocar, remove trocar and insert mesh through incision. An 11mm internal diameter trocar is recommended for a large 3dmax mesh. The sample evaluation finds for fraying of the edge seal and tearing of the mesh. As reported the user prolonged the case for an extended period of time (1-2 hours) before choosing to use an alternative device. The damage observed is consistent with user/device interface for an extended period of time during the prolongation of the case. The sample evaluation did not identify the condition of the mesh as an out of box condition. The reason for the user experiencing difficulty in placing the device initially, is unknown.
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Brand Name3DMAX
Manufacturer (Section D)
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
laura berg
100 crossings blvd.
warwick, RI 02886
MDR Report Key6544846
MDR Text Key74639815
Report Number1213643-2017-00282
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741030734
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2021
Device Catalogue Number0115311
Device Lot NumberHUAV0081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial