MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 30IN(75CM) 0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8834H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
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, a supplemental medwatch will be received.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.Is the needle piece retained in the patient? if yes, please explain.How was the needle retrieved from the patient? was there any adverse consequence associated with the patient? please provide procedure date.Please provide event date.Are unopened representative samples being returned for evaluation?.
Event or Problem Description
It was reported that a patient underwent a thoracic procedure on an unknown date and suture was used.During the procedure, the needle broke.There were no adverse events or patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/16/2020.A manufacturing record evaluation was performed for the finished device batch mph306, and no non-conformances were identified.Additional information was requested and the following was obtained: did the broken needle piece fall into the patient during the initial procedure? no.-is there any needle piece retained in the patient at the current time? no.-was an additional procedure required to remove a needle piece? no second procedure took place.- what is the date of the additional procedure? no second procedure took place.- could all needle pieces be retrieved from the patient during additional procedure? n/a, no pieces in the patient no second/ procedure took place.- are unopened representative samples being returned for evaluation? no.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 07/22/2020 additional information: d10, h6 additional h3 investigation summary: one open box with unopened samples of product code 8834, lot mph306 was received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of samples, no defects were found on the packages.The samples were opened and the swage and attachment area were noted to be as expected; also, the tip and body of the needles were examined under magnification and no defects, damage or needle breakage were found.Besides, the samples were tested by resistance test to needle and met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According to the samples conditions, no performance - breakage needle was found.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: PROLENE SUT 30IN(75CM) 0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10093884
• Report Number: 2210968-2020-04156
• Device Sequence Number: 777224
• Product Code: GAW
• UDI-Device Identifier: 10705031021051
• UDI-Public: 10705031021051
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2020

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: 11/30/2023
• Device Model Number: 8834H
• Device Catalogue Number: 8834H
• Device Lot Number: MPH306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/11/2020; 07/10/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/16/2020; 07/22/2020
• Patient Sequence Number: 1