MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D10147
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.During the procedure, when counting needles, it was noticed that one needle was missing.The needle was searched for, but could not be found, it is possible that the needle was left inside of the body.Furthermore, it did not notice when opening the package, but it is also possible that one needle was originally missing.It was not a control release needle.There were no adverse consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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.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.2 ips are open with different lot numbers.Event states one needle was missing.Should 1 ip be voided? please clarify the quantity and lot number involved.What instruments were used to grasp the needle? where was the needle grasped during use? were x-rays performed to localize the needle? are there plans for searching for the needle in the future? d4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.Corrected information: d 4.Lot, d 4.Primary udi number, h 6.Type of investigation additional information: h 6.Type of investigation ¿ analysis of production records corrected information: d4, h4 ¿ the actual device batch number associated with this event is not known.The following are the possible batch numbers: 1030as, 103mle.Batch 1030as mfg date: 8/23/2024, exp date: (b)(6) 2026.Batch 103mle mfg date: 9/27/2024, exp date: (b)(6) 2026.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information was requested, and the following was obtained: event states one needle was missing.Should 1 ip be voided? please clarify the quantity and lot number involved.Both lot numbers are the possible number.The involved qty should have been one.Are there plans for searching for the needle in the future? no.The doctor suspected that one needle had been missing before opening the package though it could not be noticed.The following information was requested, but unavailable: what instruments were used to grasp the needle? where was the needle grasped during use? were x-rays performed to localize 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.

• Brand Name: PDS PLUS VIO 18IN 4-0 S/A P-3 PRM MP
• 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: 21230918
• Report Number: 2210968-2025-00924
• Device Sequence Number: 7503815
• Product Code: NEW
• UDI-Device Identifier: 10705031219397
• UDI-Public: 10705031219397
• 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,Followup
• Report Date (Section B): 03/11/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: D10147
• Device Lot Number: 1030AS
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2024
• 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