MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 4-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP304H
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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: investigation summary (b01)- the product was returned to ethicon for evaluation.Five open samples were received for analysis.Product code pdp304h.On initial inspection of the returned sample, it was observed that four needles were correctly placed on the winding former, while one needle had been removed from the slot and inserted into a yellow sponge.The needles were examined, one needle was found bent and broken at the swage area.Besides that, marks that appear to be by a surgical instrument could be observed.In the remainder needles, no anomalies or issues related to bending needles were noted.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 due to the sample needs additional evaluation by hsa.As part of the 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.Hsa analysis: the product received for analysis was pdp304h.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.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the suture attachment of the needle.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 the sample 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.Additional h3 analysis summary (b03): the product was returned to ethicon for evaluation.Thirteen unopened samples were received for analysis.Product code pdp304h.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted as expected.The tip and body of the needles were examined, and no anomalies or issues related to bending needles were observed during the evaluation.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no bending needle was noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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 number, and no related non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a laparoscopic cholecystectomy on (b)(6) 2024 and suture was used.During continuous suturing, it was found that the needle was already unusually bent at the proximal end when the package was opened and grasped it to use.It was not used in surgery and no problems.The product was used on the abdominal cavity reinforcement suture.There were no adverse consequences to the patient.Analysis of returned product noted one needle was found bent and broken at the swage area.Besides that marks that appear to be by a surgical instrument could be observed.

• Brand Name: PDS+ VIO 27IN 4-0 S/A RB-1
• Common Device Name: SUTURE, SURGICAL, 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: 21438546
• Report Number: 2210968-2025-01987
• Device Sequence Number: 4360903
• Product Code: NEW
• UDI-Device Identifier: 10705031047976
• UDI-Public: (01)10705031047976(17)280831(10)TKMAHA
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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 Catalogue Number: PDP304H
• Device Lot Number: TKMAHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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