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	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Additional information was requested and the following was obtained: was there any patient consequences? none.Was the broken piece retrieved? yes.Did this event happened intra op? yes.Procedure.Asked to the sales rep.Lot: ppbddt.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the needle broke.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 11/9/2020 additional information: d4, h4, h6 a manufacturing record evaluation was performed for the finished device lot number ppbddt / xn8834h19, and no non-conformances related to the reported complaint condition were identified.Additional h3 investigation summary: it was reported needle rupture.Two pictures were received for evaluation.Upon visual inspection of pictures, two winding formers and a needle broken in two section near of the swage of product code 8834, lot # ppbddt could be observed.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.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.No conclusion could be reached as on what caused the needle broke since device was not returned for analysis.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: 10673199
• Report Number: 2210968-2020-07943
• Device Sequence Number: 11503973
• Product Code: GAW
• UDI-Device Identifier: 10705031021051
• UDI-Public: 10705031021051
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/28/2020

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: 11/30/2024
• Device Model Number: 8834H
• Device Catalogue Number: 8834H
• Device Lot Number: PPBDDT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/09/2020
• Patient Sequence Number: 1