MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 3-0 S/A PS-1 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	1663G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
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.Additional information was requested, and the following was obtained: *please clarify, which part of the device broke during the procedure, the suture or the needle? the needle broke.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a spine procedure on (b)(6) 2020; and a suture was used.During the procedure, the needle broke.The procedure was completed successfully.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
One needle of product code 1663, lot qbbbxx was submitted for fractological evaluation.A fracture was observed at the tip of sample a.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.The evaluation revealed the fractures were mixed mode with transgranular cleavage and microvoid coalescence.This was mixed mode fracture.The needle fractured due to a mixed mode failure.The needle exhibited amounts of ductile and non-ductile features.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
Date sent to the fda: 08/27/2020.Additional information: a manufacturing record evaluation was performed for the finished device lot number qbbbxx and no non-conformances were identified.Additional h-3 summary: representative sample: one unopened sample of product was received for analysis.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected; also, the tip and body of the needle were examined under magnification and no defects, damage or needle breakage were found.Besides, the sample was tested by resistance test to needle and met the requirements.According to the sample condition, no performance - breakage needle was found actual: one needle of product was received for analysis.During the visual inspection of the sample, the needle was received broken at the tip area, body fluids could be observed, and marks were present due to use.Due to condition of the broken needle, additional evaluation is necessary to determine the assignable cause.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-1 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: 10448428
• Report Number: 2210968-2020-06343
• Device Sequence Number: 11676476
• Product Code: GAR
• UDI-Device Identifier: 10705031001725
• UDI-Public: 10705031001725
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2020

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 Expiration Date: 01/31/2025
• Device Model Number: 1663G
• Device Catalogue Number: 1663G
• Device Lot Number: QBBBXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/25/2020; 09/08/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 08/27/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1