MAUDE Adverse Event Report: ETHICON INC. GUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1916G
Health Effect - Clinical Codes	Wound Dehiscence (1154); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of the index procedure date of the index surgical procedure? what was tissue type and location of suture placement? what tissue dehisced? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was suture initially placed (interrupted or continuous)? how was the suture initially tied? was there any precipitating stress factor for the suture untying, breakage or pulling out of the tissue? what was the appearance of the suture during reoperation? did the suture break or did the tissue pull away from the suture? did the operating surgeon observe any suture anomaly before, during, after the suture placement or during any re-operation? lot #? what is surgeon's opinion as to the etiology of or contributing factors to the event? does surgeon believe there is any deficiency with the suture? what is the patient¿s current status?.
Event or Problem Description
It was reported that a patient underwent cleft palate procedure on unknown date and suture was used.Three days post operation the wound of the patient ruptured along the incision line.An additional procedure was performed to re-suture the wound.Additional information has been requested.
Additional Manufacturer Narrative
The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: for product code 1916g, the lot number is jkk645, expiration date 8/31/2020.

• Brand Name: GUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7569653
• Report Number: 2210968-2018-73307
• Device Sequence Number: 2012192
• Product Code: GAL
• UDI-Device Identifier: 10705031002920
• UDI-Public: 10705031002920
• Combination Product (Y/N): N
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 1916G
• Device Lot Number: JKK645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention