MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 6-0 S/A P-1 PRM; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z489G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2023 and suture was used.The suture was easily detached during use on the patient.There were no adverse patient consequences.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Additional information was requested and the following was obtained: when did the needle detach/pull off from the suture (in the package, during removal from the package, during handling before use on patient or during use on the patient)?: during use on the patient; please provide the lot number: unknown.The product was discarded by customer; were there any patient consequences?: no; procedure name and date?: unknown.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.

• Brand Name: PDSII CLR 18IN 6-0 S/A P-1 PRM
• 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: 17965367
• Report Number: 2210968-2023-07994
• Device Sequence Number: 6799689
• Product Code: NEW
• UDI-Device Identifier: 10705031061132
• UDI-Public: 10705031061132
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: N18331
• 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: Z489G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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