MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 36IN 5-0 D/A RB-2 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPH8716H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Attempts have been made to retrieve the device.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.When did the needles 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)? please specify.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).Events reported via: mwr-29122023-0001543085, mwr-29122023-0001543086.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture was detached from the needle easily.It was not a control release needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/9/2024.H6 component code: g07002 no device problem found.Additional information was requested, the following was obtained: when did the needles 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)? please specify: unk.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) :(b)(6).Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections: the device has been received at sukagawa and will be shipped.Please check rmao.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample determined that it was received, one needle-suture piece and one detached needle outside its packaging that pertained to the product code eph8716h.The product code is double-armed.Upon visual inspection of the returned sample, the swage and attachment were noted to be as expected.The suture piece was examined, and the extreme was noted to be cut probably caused by a surgical instrument.Also, the functional test was performed using instron equipment and the pull force result was above the minimum requirements.In order to evaluate the conditions of the detached needle, the swage area and hole were noted with marks by a surgical instrument.The hole was examined under magnification and a remnant of suture was observed.In addition, the other section of the suture piece wasn¿t received.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: PRLNE HS BLU 36IN 5-0 D/A RB-2 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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 PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18520522
• Report Number: 2210968-2024-00445
• Device Sequence Number: 12457263
• Product Code: GAW
• UDI-Device Identifier: 10705031233515
• UDI-Public: 10705031233515
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/09/2024

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: EPH8716H
• Device Lot Number: TBBJZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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