MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 18IN 5-0 S/A PS-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8681H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
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.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.Additional information was requested and the following was obtained: did the suture break or did the needle separate from the suture during this patient procedure? reply: needle and suture separated from each other.Do you have a photo for visual analysis? reply: no.Lot number? reply: qkbbcz.What tissue was being approximated or sutured when it broke? reply: skin texture.Were there any adverse patient consequences? reply: no.Procedure date? reply: (b)(6) 2022.Events reported via 2210968-2022-00769.
Event or Problem Description
It was reported that a patient underwent a facelift surgery on (b)(6) 2022 and suture was used.During the procedure, the suture and needle separated.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).Date sent to the fda: 4/6/2022.H6 component code: g07002 device not returned.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: d4, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via 2210968-2022-00769.

• Brand Name: PROLENE BLU 18IN 5-0 S/A PS-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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 PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13415703
• Report Number: 2210968-2022-00770
• Device Sequence Number: 4826455
• Product Code: GAW
• UDI-Device Identifier: 10705031091368
• UDI-Public: 10705031091368
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 8681H
• Device Catalogue Number: 8681H
• Device Lot Number: QKBBCZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2022
• Supplement Date Received by Manufacturer: 03/26/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown