MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8699G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The following information was requested, but unavailable: could you please confirm the quantity of procedures that were affected by "needle falling off"? could you please specify the quantity of devices that presented "needle falling off" during each procedure? what was being done when the needles fell off (e.G.Removal from package, during passage through tissue, during tying, post-op, etc.)? were there any patient consequences? name and date of the procedure(s)?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2021 and suture was used.During the procedure, the needle keeps falling off.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 06/17/2021.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.Investigation summary: the product was returned to ethicon inc for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that six samples of product code 8699 were received for evaluation.Visual inspection of six unopened samples and no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The device performed without any defect noted and the complaint sample was not received for evaluation.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Device history lot: "a manufacturing record evaluation was performed for the finished device batch qgbdjm, 8699g56 and no non-conformances were identified.

• Brand Name: PRLNE BLU 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11672517
• Report Number: 2210968-2021-03398
• Device Sequence Number: 3196493
• Product Code: GAW
• UDI-Device Identifier: 10705031019263
• UDI-Public: 10705031019263
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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 Expiration Date: 05/31/2025
• Device Model Number: 8699G
• Device Catalogue Number: 8699G
• Device Lot Number: QGBDJM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1