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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6.Component code: g07002 - device not returned.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.Additional information was requested, and the following was obtained: * if the needle broke, did any piece fall in the patient? if yes, how was it retrieved? no needle pieces fell into the body due to needle breakage.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.* can you identify the lot number of the product used? * please clarify if the suture broke, or the needle broke, or if the entire suture detached/pulled off from the needle.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.
Event or Problem Description
It was reported that a patient underwent an unknown orthopedic procedure on an unknown date and a suture was used.The connection part of the suture and needle (the swage part) was broken during use.It was not a control release needle.No adverse patient consequences were reported.Additional information was requested.
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.Corrected information: h6.Additional information was requested, and the following was obtained: can you identify the lot number of the product used? unk.Please clarify if the suture broke, or the needle broke, or if the entire suture detached/pulled off from the needle.We were reported that the needle broke off at the swage part.If the needle broke, did any piece fall in the patient? no.

• 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21172011
• Report Number: 2210968-2025-00641
• Device Sequence Number: 4276090
• Product Code: NEW
• UDI-Device Identifier: 10705031047976
• UDI-Public: 10705031047976
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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