MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN(45CM) USP4-0(M1.5) S/A SH CR; SUTURES - ABSORBABLE

Catalog Number	PDP773D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.The suture was broken when the surgeon attempted to sew the tissue.Changed to another one to complete the surgery.There were no adverse patient consequences reported.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).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, or its employees that the report constitutes an admission that the product, ethicon, 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.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned product determined that it was received one open sample that pertained to the product code pdp773d.This product code is control release and requires eight strands.During visual inspection of the returned sample, it was noted that the winding former contains six needle suture pieces and two needle suture combinations.The sutures were examined and the end of six sutures was noted to be cut probably caused by a surgical instrument.In the remainder, no anomalies or issues related to breakage sutures were observed.The product code pdp773d contains an absorbable suture.As the sample was received open, and the time of exposure to the environment cannot be determined.Due to the condition of the returned sample, the functional test could not be performed.The instructions for use do contain the following caution: as with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.As part of the 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 review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• Brand Name: PDS PLUS VIO 8X18IN(45CM) USP4-0(M1.5) S/A SH CR
• Common Device Name: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18398885
• Report Number: 2210968-2023-10161
• Device Sequence Number: 19522939
• Product Code: NEW
• UDI-Device Identifier: 10705031218765
• UDI-Public: 10705031218765
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K061037
• 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

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: 03/31/2024
• Device Catalogue Number: PDP773D
• Device Lot Number: SDMQMJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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