MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 3-0 S/A PS-2 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	1669H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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.What was the initial procedure? what is the event day and procedure date? what is the lot number?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2020 and suture was used.During the procedure, the needle broke.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/26/2020.A manufacturing record evaluation was performed for the finished device lot number kde645, and no non-conformances related to the reported complaint condition were identified.Mfg.Date -4/5/2016.Exp.Date -3/31/2021.A manufacturing record evaluation was performed for the finished device lot number kgj460, and no non-conformances related to the reported complaint condition were identified.Mfg.Date -6/21/2016.Exp.Date -5/31/2021.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
(b)(4) date sent to the fda: 1/26/2021 additional information: b3, g1 additional information: d4 - the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch kgj460.Batch kde645.Additional information was requested and the following was obtained: what was the initial procedure? rhinoplasty what is the event day and procedure date? (b)(6) 20020 what is the lot number? customer couldn't remember the exactly lot number that they used, however they supposed to be lot kgj460 or lot kde645.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.

• Brand Name: ETHLN BLK 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10909978
• Report Number: 2210968-2020-09380
• Device Sequence Number: 3170364
• Product Code: GAR
• UDI-Device Identifier: 10705031001879
• UDI-Public: 10705031001879
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020

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 Model Number: 1669H
• Device Catalogue Number: 1669H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 01/26/2021; 01/26/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/26/2021; 01/26/2021
• Patient Sequence Number: 1