MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 24IN(60CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8304H
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 a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on an unknown date and suture was used.The needle was broken at the swage part at the second passing of the needle during anastomosis.No broken piece was dropped in the patient¿s body.There were no adverse consequences to the patient.

• Brand Name: PROLENE SUT 24IN(60CM) 7-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8782270
• Report Number: 2210968-2019-84116
• Device Sequence Number: 16628680
• Product Code: GAW
• UDI-Device Identifier: 10705031014114
• UDI-Public: 10705031014114
• 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
• Report Date (Section B): 06/17/2019

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 Catalogue Number: 8304H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/11/2019
• Patient Sequence Number: 1