MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGILON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number 88861927-32

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during craniotomy procedure, the two device's needles was broke while suturing on the dura and fell into patient cavity.The tip of needle was found by the surgeon.No patient injury.

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of four photographs of a device.The visual inspection of the photographs noted one needle and one retainer.The needle was observed to be broken at the tip; the broken tip was not shown in the photos.The retainer was visually observed to have no abnormalities.As no products were returned, functional testing was precluded.The root cause of the broken needle tip couldn¿t be determined because no products were returned.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGILON
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7143523
• MDR Text Key: 95732488
• Report Number: 9612501-2017-06836
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 20884521072043
• UDI-Public: 20884521072043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 88861927-32
• Device Catalogue Number: 88861927-32
• Device Lot Number: D7A0483X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1