MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8683G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the 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.Confirm if all 6 sutures reported to be broken during the same procedure? if yes, did all 6 sutures break intra-op=during use om patient? or noticed to be broken pre-op= during handling /before use on patient? any patient consequence? was procedure completed successfully?.
Event or Problem Description
It was reported that the patient underwent a biopsy procedure in 2019 and the suture was used for excision.During the surgery, the suture broke at spot along the blue nylon.There is no specific area of the body where breakage has occurred.There were no patient consequences reported.
Additional Manufacturer Narrative
Date sent to the fda: 02/14/2020.A manufacturing record evaluation was performed for the finished device batch pgp456, 8683g56 and no non-conformances were identified.Additional h-3 summary: an empty overwrap packet and a needle/ suture piece of product code 8683, lot # pgp456 were received for evaluation.During the visual inspection of the needle/suture piece marks on body needle could be observed and the end of the suture was noted with a lineal cut appears to be by use of a surgical instrument.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.Per the sample condition, the assignable cause of the performance suture breakage is an improper handling 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.One device was returned with lot number pgp456 which is different than a lot reported in this complaint initially ( pdh960).Please explain why the device with lot pgp456 was returned for evaluation and clarify if this lot pgp456 is involved in this event?.

• Brand Name: PROLENE SUTURE 18"(45CM) 4-0 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: 9501620
• Report Number: 2210968-2019-91141
• Device Sequence Number: 1853839
• Product Code: GAW
• UDI-Device Identifier: 10705031018914
• UDI-Public: 10705031018914
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2019

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: 05/31/2024
• Device Model Number: 8683G
• Device Catalogue Number: 8683G
• Device Lot Number: PGP456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/14/2020
• Patient Sequence Number: 1