MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	699H
Medical Device Problem Codes	Positioning Failure (1158); Product Quality Problem (1506)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a hand surgery on an unknown date and suture was used.During the procedure, the knot opened.A dehiscence occurred.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Device not returned.Attempts have been made to retrieve the device.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.Did the suture knots untie intraoperatively ? suture knots untie post - operatively ? when did the dehiscence occur ? was there any need of medical or surgical intervention ? number of affected sutures ? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? did the suture knots untie intra-operatively ? did the suture knots untie post -operatively ? how many sutures untied? what tissue dehisced? when did the dehiscence occur? intra-op or post-op? if post-op, what was the onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any medical/surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure, if applicable.Were there any precipitating stress factors for the sutures untying? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.Note: event reported via 2210968-2022-01364, 2210968-2022-01365.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/28/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional h6 component code: g07002 reported condition not confirmed.Additional h3 investigation summary: one opened box with thirty-six packets of product code 699h was returned to ethicon inc for analysis.Upon initial inspection of the samples, no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to damaged or breakage sutures and no defects were observed during evaluation.Also, a knot in the threads was performed and they did not untie after being tied knot.In addition, a functional test was performed using an instron and the tensile strength force was above the minimum requirement.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The following information was requested, but unavailable: did the suture knots untie intraoperatively ? suture knots untie post - operatively ? when did the dehiscence occur ? was there any need of medical or surgical intervention ? number of affected sutures ? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? did the suture knots untie intra-operatively ? did the suture knots untie post -operatively ? how many sutures untied? what tissue dehisced? when did the dehiscence occur? intra-op or post-op? if post-op, what was the onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any medical/surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure, if applicable.Were there any precipitating stress factors for the sutures untying? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/1/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: sales rep provided the following: surgeon is not willing to provide what he considers to be too much information.Wound dehiscence occurred postoperatively, and the secondary suture was sutured with foreign material.Corrected information: h6 device code, h6 health impact code.

• Brand Name: ETHLN BLK 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13618325
• Report Number: 2210968-2022-01366
• Device Sequence Number: 5731353
• Product Code: GAR
• UDI-Device Identifier: 10705031008632
• UDI-Public: 10705031008632
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/06/2022

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?: Yes
• Device Expiration Date: 04/30/2026
• Device Model Number: 699H
• Device Catalogue Number: 699H
• Device Lot Number: REBAEK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 01/31/2022; 03/10/2022; 04/06/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/01/2022; 03/28/2022; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown