MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Model Number	C017D
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Photo analysis: an image was submitted for evaluation and upon visual inspection of the image, a winding former with eight strands and a damaged paper lid, product code: c017d, was observed.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.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested, and the following was obtained: 1.Any hole, tear, or puncture that compromises sterility? no.2.Was the seal broken prior to opening? no.3.Was the packaging tempered? no.4.Was there damage to the carton box? unknown.5.Is there foreign matter inside the package? no.6.Procedure name and date? unknown.7.Event date? (b)(6) 2022.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.It was noted there was package damage.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4)date sent to the fda: 7/19/2022 this report is being submitted pursuant to the provisions of 21 cfr, part 803.Part 4 subpart b.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: investigation summary: one unopened sample of product code c017d was returned for evaluation.Visual inspection was conducted on the returned device.Upon visual inspection of the returned sample; it was observed damaged on the copolymer of the packaging appears to be caused by an unknown object.The damage was examined under 20x magnification, and the integrity of the packet was not compromised since damage did not cause perforation on copolymer.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.The condition of the sample received indicates improper handling of the device.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 8/8/2022.H3 investigational summary: one unopened sample of product code c017d was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Upon visual inspection of the returned sample; it was observed damaged on the copolymer of the packaging appears to be caused by an unknown object.The damage was examined under 20x magnification, and the integrity of the packet was not compromised since damage did not cause perforation on copolymer.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.The condition of the sample received indicates improper handling of the device.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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: SILK SUTURE 30"(75CM) 3-0 BLK
• 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
• MDR Report Key: 14627489
• Report Number: 2210968-2022-04363
• Device Sequence Number: 17403743
• Product Code: GAP
• UDI-Device Identifier: 10705031023499
• UDI-Public: 10705031023499
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2022

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: 05/31/2024
• Device Model Number: C017D
• Device Catalogue Number: C017D
• Device Lot Number: PGJ757
• 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: 05/12/2022
• Supplement Date Received by Manufacturer: 06/24/2022; 07/20/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/19/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2019
• 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