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	06/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Other information requested is unknown.Did the needle fall into the patient? if yes, ¿ was the needle piece(s) retrieved during the same procedure? ¿ were x-rays taken to locate the needle piece(s)? ¿ what measures were taken to retrieve the broken piece? ¿ was there any additional tissue damage as a result of searching for the needle piece? - does a piece of the needle remain in the patient¿s tissue? if yes, ¿ is there any plan in place to remove the needle piece in the future? ¿ if yes, please provide the scheduled date.¿ what tissue structure the broken needle was located? ¿ what is the surgeon's opinion of consequences to the patient? - were there any unexpected outcomes or complications as a result of the prolonged surgery time? - how long (in minutes) did the surgery prolong? ¿ what tissue was being sutured when the event occurred? - was additional dissection required in other organs/tissues other than the target tissue? - was there any change in the patient¿s post operative care due to the prolonged procedure? a review of the batch manufacturing records was conducted, and no related non-conformances were identified.No product available for return.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, 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 a patient underwent a left perineal incision wound on (b)(6) 2023 and suture was used.During the process of suturing the patient's skin, medical staff found that the needle tip broke while fixing the first needle.Immediately replace the new suture and request the midwife to check if the suture is intact and free of defects when taken out of the packaging.Finally, complete the skin suture of the lateral incision wound.This incident delayed the patient's treatment.Additional information has been 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: 18408960
• Report Number: 2210968-2023-10215
• Device Sequence Number: 12939263
• Product Code: GAM
• UDI-Device Identifier: 10705031134799
• UDI-Public: 10705031134799
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2023

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: AT2557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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 Age: 43 YR
• Patient Sex: Female