MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 18IN 5-0 S/A PS-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8681H
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).Additional information was requested, and the following was obtained: what was the name of this surgical procedure? unknown.Did the needle break or did the needle pulled off from the suture when removed from the packaging? needle pulled off when taken from packaging.Please confirm device issue occur before use on patient or during actual suturing? yes.Procedure name and date? unknown.Event date? unknown.How was case completed? with new suture.Any adverse patient consequences and what medical/surgical intervention was performed to manage them? no.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date, and a suture was used.During the procedure, the suture broke while suturing.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/28/2020.Corrected information: b1, h1 - additional information was received and the reported event did not occur.This event is therefore, not malfunction reportable and this medwatch report is being voided.

• Brand Name: PROLENE BLU 18IN 5-0 S/A PS-3 PRM MP
• 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: 10586480
• Report Number: 2210968-2020-07325
• Device Sequence Number: 19527824
• Product Code: GAW
• UDI-Device Identifier: 10705031091368
• UDI-Public: 10705031091368
• 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
• Report Date (Section B): 09/15/2020

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 Model Number: 8681H
• Device Catalogue Number: 8681H
• Device Lot Number: QABJMD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1