MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 27"(70CM) 2-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP969H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.Attempts have been made to retrieve the device.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 via: i have forwarded your message to our doctors to get you the information you need on the suture.What i have been told is that the suture is breaking with very little pressure.I have the boxes ready to send in but was not given the address or information to send back to you.It was reported that "¿they are having issues with the box of suture.All four doctors were reporting breakage of the suture and not under pressure." please provide information requested for each patient/event listed below: (b)(4) suture breakage reported by 1st surgeon.(b)(4) suture breakage reported by 2nd surgeon.(b)(4) suture breakage reported by 3rd surgeon.(b)(4) suture breakage reported by 4th surgeon what are the procedure name(s) and date(s)? can you identify the lot numbers of the product that was used? what is the quantity of devices involved? please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Please confirm if the devices are available for product return.If yes, please confirm the quantity of devices to be returned and provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.The manufacturing records could not be reviewed as the batch/lot number is unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2024 and suture was used.During the procedure, it was reported by healthcare professional that they are having issues with the box of suture.All four doctors were reporting breakage of the suture and not under pressure.Device availability unknown.There were no adverse consequences reported.No further information was 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.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Following additional information was received: i have forwarded your message to our doctors to get you the information you need on the suture.What i have been told is that the suture is breaking with very little pressure.I have the boxes ready to send in but was not given the address or information to send back to you.

• Brand Name: PDS PLUS SUTURE 27"(70CM) 2-0 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: 20599261
• Report Number: 2210968-2024-11439
• Device Sequence Number: 8943612
• Product Code: NEW
• UDI-Device Identifier: 10705031048690
• UDI-Public: 10705031048690
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: PDP969H
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/27/2024
• 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