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

Model Number	641G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a an unknown dental and oral surgery, on (b)(6) 2022 and suture was used.During the procedure, the needle was detached from the suture when the surgeon pulled the product to use it.The same thing happened three times in a row.These were not control release needles.Upon evaluation of the returned device, the needle was broken there were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but was unavailable: - it was reported the needle was detached from the suture when the surgeon pulled the product to use it, could you please confirm the issue happened during removal from package? if not, please specify=>no further information is available.Device return status: no further information will be provided qty of product involved : 1 => 3.Investigation summary: one open box with six packets of product code 641g were returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.In order to evaluate the condition of the returned samples, the packets were opened and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no anomalies were observed during evaluation.Functional test was performed, and the pull force result were above the minimum requirements.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional investigation summary: a failed suture needle, labeled as (b)(4), was submitted fractographic evaluation on july 29, 2022.The component was identified as product code 641g.It was requested that assess the fracture mode of the failure.A fracture was observed at the suture attachment of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The needle breakage was confirmed.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: SILK BLK 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• 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 ; 9083863534
• MDR Report Key: 15214436
• Report Number: 2210968-2022-06500
• Device Sequence Number: 20336977
• Product Code: GAP
• UDI-Device Identifier: 10705031007390
• UDI-Public: 10705031007390
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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: 07/31/2026
• Device Model Number: 641G
• Device Catalogue Number: 641G
• Device Lot Number: RJBALT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/11/2022
• Date Device Manufactured: 08/03/2021
• 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