MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 7-0 S/A P-1 PRM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8696G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
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 a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: please provide specific number of devices with suture breakage issue during use in this procedure.=> 12 devices were reported as nonconforming.How was case completed? => no further information is available.No further information will be provided.Note: events reported in: 2210968-2019-89222, 2210968-2019-89223, 2210968-2019-89224, 2210968-2019-89225, 2210968-2019-89226, 2210968-2019-89227, 2210968-2019-89228, 2210968-2019-89229, 2210968-2019-89230, 2210968-2019-89231, 2210968-2019-89232, and 2210968-2019-89233.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2019 and suture was used.During the procedure, the surgeon felt that the suture was broken easily.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 11/04/2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PRLNE BLU 18IN 7-0 S/A P-1 PRM
• 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: 9256092
• Report Number: 2210968-2019-89233
• Device Sequence Number: 11276313
• Product Code: GAW
• UDI-Device Identifier: 10705031019188
• UDI-Public: 10705031019188
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/02/2019

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: 11/30/2023
• Device Catalogue Number: 8696G
• Device Lot Number: MPH394
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/04/2019
• Patient Sequence Number: 1