MAUDE Adverse Event Report: ETHICON INC. VCL RAP UD 27IN 3-0 S/A PS-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR935
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/21/2024
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.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.The following information was requested, but unavailable: please confirm if the patient required " secondary or even tertiary sutures".Were there any unexpected outcomes or complications as a result of the prolonged surgery time? were there any patient consequences? please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).D4: udi: as the serial 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 a perineal laceration procedure on (b)(6) 2024 and suture was used.During the procedure, the nursing staff performed perineal suturing and knotting on a parturient with a perineal laceration.When the suture broke, the nurse immediately replaced it and removed the previously stitched material to re suture it until the surgery was completed.This event resulted in an extended surgical time, and the torn skin of the patient may require secondary or even tertiary sutures, increasing the patient's psychological burden.Additional information was requested.

• Brand Name: VCL RAP UD 27IN 3-0 S/A PS-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19921607
• Report Number: 2210968-2024-08040
• Device Sequence Number: 20861372
• Product Code: GAM
• UDI-Device Identifier: 10705031134799
• UDI-Public: (01)10705031134799(11)230915(17)280831(10)AU8938
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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: VR935
• Device Lot Number: AU8938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2023
• 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: Female