MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 4-0 D/A V-7; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	W8845
Medical Device Problem Code	Material Separation (1562)
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 clarify more information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify what does it mean ¿ cvs¿ procedure? could you please specify a lot number for suture w8845 which involved in this event? additional information was requested, and the following was obtained: does the needle detach from the suture during surgery? yes.Does the suture break and also does the needle break in pieces during surgery? no.What is the name of the procedure? cvs.What is the event day? unknown.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent an unknown cvs procedure in 2020 and the suture was used.During surgery, the needle detached from the suture easily.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: please clarify what does it mean ¿ cvs¿ procedure? cardiovascular surgery.Could you please specify a lot number for suture w8845 which involved in this event? lot number is not available.

• Brand Name: PRLNE BLU 36IN 4-0 D/A V-7
• 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: 10113289
• Report Number: 2210968-2020-04319
• Device Sequence Number: 13982056
• Product Code: GAW
• UDI-Device Identifier: 10705031231726
• UDI-Public: 10705031231726
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: W8845
• Device Catalogue Number: W8845
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/04/2020
• Patient Sequence Number: 1