MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 8"(20CM) 3-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8534H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: lot #? mle043 was the lot # provided to me.What do you mean by "needles breaking off from suture material"? the whole needle separated / detached from the whole suture thread.The needle did not break in half.Confirm the total qty involved for this reported event ? this happened to 5 eaches during the same procedure.They sent back 13 unopened eaches.Events reported in 2210968-2019-88434, 2210968-2019-88435, 2210968-2019-88437, 2210968-2019-88438.
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 needle broke off from suture material.The whole needle separated / detached from the whole suture thread.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported performance pull off suture needle.An opened box with thirteen unopened samples of product code 8534 lot # mle403 were returned for analysis.During the visual inspection of thirteen unopened samples, no defects were found on the packages.The samples were opened, and 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 manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the sample received, no performance pull off suture needle was found, and the tested sample met the finished goods requirements.

• Brand Name: PROLENE SUTURE 8"(20CM) 3-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9165714
• Report Number: 2210968-2019-88436
• Device Sequence Number: 16792385
• Product Code: GAW
• UDI-Device Identifier: 10705031016774
• UDI-Public: 10705031016774
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 09/30/2023
• Device Catalogue Number: 8534H
• Device Lot Number: MLE043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/06/2019
• Patient Sequence Number: 1