MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 36"(90CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP358T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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: the product was returned to ethicon for evaluation.One labeled winding former with a undispensed strand and one detached needle outside were received for analysis.The product code is pdp358t.Upon visual assessment of the sample, the swage and attachment area were noted to be as expected.The barrel hole was examined, and remnant of suture was observed.The sutures cannot be dispensed since have begun the degradation process this condition probably caused the detached needle.Per the sample condition, the functional test cannot be performed.The foil was not returned to analysis.The product code pdp358t contains an absorbable suture.As the sample was received open, the time of exposure to the environment could not be determined and the functional test could not be performed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached as to what may have caused the reported incident.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The manufacturing records could not be reviewed as the batch/lot number is unknown.
Event or Problem Description
It was reported that a patient underwent an arthroplasty procedure on (b)(6) 2024 and suture was used.Before use on the patient, it was reported that the problem of pulling off suture needle had happened in the newly dispensed suture when it was opened to prepare for surgery.Changed another one to complete the surgery.Upon visual assessment of the sample, the swage and attachment area were noted to be as expected.The barrel hole was examined, and remnant of suture was observed.The sutures cannot be dispensed since have begun the degradation process this condition probably caused the detached needle.No additional information could be provided.The lot of the ip is unavailable.There were no adverse consequences reported.Additional information was requested.

• Brand Name: PDS PLUS SUTURE 36"(90CM) 0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20242061
• Report Number: 2210968-2024-09889
• Device Sequence Number: 8755083
• Product Code: NEW
• UDI-Device Identifier: 10705031048171
• UDI-Public: 10705031048171
• 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
• Report Date (Section B): 09/17/2024

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: PDP358T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown