MAUDE Adverse Event Report: ETHICON INC. VCL CT UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J426H
Health Effect - Clinical Codes	Abscess (1690); Pain (1994); Swelling (2091); Not Applicable (3189)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.An empty opened box and two unopened samples of product code of j426, lot kcz763 were returned for analysis.The representative samples were examined for visual defects: appearance, color packages, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured).The packets were opened and during the visual inspection, the sutures were correctly placed on the winding former and the sutures were dispensed without problems and examined along of the strands and no defects or damage were observed.Per the condition of the representative samples, no defects were observed on the packets or the sutures.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.What was tissue location for the placement of the v416h and v426h sutures? what was the tissue condition at placement, i.E., normal or thin, calcified, fragile, diseased? was the wound cultured? if yes, results? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.
Event or Problem Description
It was reported that the patient underwent achilles tendon repair and graft on (b)(6) 2018 and suture was used.On (b)(6) 2018, the patient returned due to pain and swelling.The patient was administered antibiotics when he presented with issues.On (b)(6) 2018, the patient was brought back to surgery for deep suture abscess.During the reoperation, the surgeon stated you could see where stitches had been and the tissue seemed rotted.The patient underwent i&d, debridement with wound vac.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: what was tissue location for the placement of the v416h and v426h sutures? right posterior ankle, achilles repair was initial surgery what was the tissue condition at placement, i.E., normal or thin, calcified, fragile, diseased? normal.Was the wound cultured? if yes, results? yes, preliminary negative, final result sparse (b)(6).What is the physician¿s opinion as to the etiology of or contributing factors to this event? neglected achilles rupture x 8-12 months.What is the patient¿s current status? 4 weeks non-wt.Bearing with wound vac.X 1 week.Healing well except for one open area.

• Brand Name: VCL CT UD 27IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7806944
• Report Number: 2210968-2018-75341
• Device Sequence Number: 13846445
• Product Code: GAM
• UDI-Device Identifier: 10705031039773
• UDI-Public: 10705031039773
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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: 02/28/2021
• Device Catalogue Number: J426H
• Device Lot Number: KCZ763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 08/28/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention