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	05/14/2020
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).Additional information was requested and the following was obtained: initial procedure took place on (b)(6) 2020.What is the event day? (b)(6) 2020.What is current condition of the patient? good.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.What is the date of the additional procedure? n/a.Could all needle pieces be retrieved from the patient during additional procedure? n/a.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 7/8/2020 additional information: d4, h4, h6 a manufacturing record evaluation was performed for the finished device batch mph306, xn8834h19 and no non-conformances were identified.

• 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: 10093901
• Report Number: 2210968-2020-04155
• Device Sequence Number: 16337846
• 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: company representative,foreig
• 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?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/05/2020; 06/29/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/09/2020; 07/08/2020
• Patient Sequence Number: 1