MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 0 S/A CT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8434H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: was surgery delayed due to the reported event? unknown.Was procedure successfully completed? unknown.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.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) please perform and document the follow-up attempt for product return.The photo upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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 total mastectomy, tahbso and abdominoplasty on (b)(6) 2024 and suture was used.During case, the suture broke from the tip of the needle.And according to dr.The suture is too fragile, need to replace a new suture.Additional information has been 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.H6 component code: c22 - photo analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Photo review: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a needle separated from the suture, a remnant of suture is still attached to the needle.Due to the quality of the image a clear analysis could not be performed.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.
Additional Manufacturer Narrative
Product complaint # (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, 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: PRLNE BLU 30IN 0 S/A CT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19748870
• Report Number: 2210968-2024-07241
• Device Sequence Number: 6579361
• Product Code: GAW
• UDI-Device Identifier: 10705031015593
• UDI-Public: (01)10705031015593(17)271031(10)SMBDXA
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K133356
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2024

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: 8434H
• Device Lot Number: SMBDXA
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 10/16/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 09/20/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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 Sex: Female