MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 2-0 D/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8523H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not confirmed.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.H3 evaluation: the product was returned to ethicon for evaluation.One open sample with a needle-suture piece and one suture piece was received for analysis.Product code.During the visual inspection of the needle, the swage and attachment area were noted to be as expected.However, marks were noted on the body.The received suture was inspected, and no breakage suture was observed.But the suture was cut and knotted.Besides that, the extremes were noted to be cut and some damaged (crushed) on the surface probably caused by a surgical instrument.As per the returned conditions of the sample, no functional test was performed.As part of our quality process, the manufacturing records of this lot- were reviewed, and the manufacturing standards were met prior to the release of this batch.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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 an unknown procedure on (b)(6) 2024 and suture was used.The suture was broken when the surgeon attempted to sew the tissue.Changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.Additional information has been requested.

• Brand Name: PRLNE BLU 36IN 2-0 D/A SH
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20901471
• Report Number: 2210968-2024-13209
• Device Sequence Number: 20085057
• Product Code: GAW
• UDI-Device Identifier: 10705031016590
• UDI-Public: (01)10705031016590(17)281130(10)TPBEJH
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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: 8523H
• Device Lot Number: TPBEJH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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: Unknown