MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGITIE; SUTURE, ABSORBABLE, NATURAL

Model Number	EL-21-L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was previously submitted on a summary report.Subsequently, medtronic has received additional information which is being submitted via this 3500a.Post market vigilance (pmv) led an evaluation of one device.Pmv received one open sample of surgitie ligating loop.The tubing was fractured, and the device was un-cinched.The device was seated in the blister improperly.The fractured end of the tubing was not able to fit within the blister, and the distal end of the tubing was bent upwards.An engineering evaluation of the returned product noted that there was no evidence to associate the reported condition to any material defect or manufacturing process.The engineering team was able to replicate the reported condition by removing the device from the blister in a horizontal direction instead of a perpendicular direction.It is possible that removing the device in this way could have bent the distal end of the tubing and fractured it at the break point.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.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.
Event or Problem Description
According to the reporter: occurred during an laparoscopic appendectomy procedure to treat a patient with acute appendicitis.The device was broken before use.No patient injury or extension in surgical time.

• Brand Name: SURGITIE
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7507639
• Report Number: 9612501-2018-00978
• Device Sequence Number: 2194588
• Product Code: GAL
• UDI-Device Identifier: 10884521099630
• UDI-Public: 10884521099630
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K904588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: EL-21-L
• Device Catalogue Number: EL-21-L
• Device Lot Number: J6F2928X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1