MAUDE Adverse Event Report: HALYARD HEALTH GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY* T-FASTENERS; DH EF PERC PLACEMENT PRODUCTS

Model Number 98701

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history records (dhr) were reviewed for lot number aa6131r01 and the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.All information reasonably known as of (b)(4) 2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4) device not returned.

Event Description

Halyard received a single report that referenced two different incidences, which were associated with separate units, involving one patient.This is the first of two reports.Refer to 9611594-2017-00150 for the second report.It was reported that the t-fastener kept breaking during the procedure and occurred on one patient.There was no injury to the patient.An additional set of t-fasteners were opened; however, the exact quantity is unknown.Additional information was received from the surgeon on (b)(6) 2017 that states there were two different packages opened and they both broke.The surgeon stated that the t-fasteners felt thinner than usual.The t-fasteners broke when they initially tried to secure them.The procedure was completed without the t-fasteners.No additional information was provided.

• Type of Device: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industrial no 40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7076941
• MDR Text Key: 93723341
• Report Number: 9611594-2017-00149
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 10680651987010
• UDI-Public: 10680651987010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/01/2018
• Device Model Number: 98701
• Device Catalogue Number: 991098701
• Device Lot Number: AA6131R01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR