MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 48IN 3-0 D/A MH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	D5636
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).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.What was the procedure? could you please confirm if the suture broke or the issue was that suture was fragile without any breakage? what is the event day and procedure date? what is the lot number? could you please confirm device's availability? 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; a suture was used.During the procedure, the suture broke easily.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 48IN 3-0 D/A MH
• 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: 10560241
• Report Number: 2210968-2020-07141
• Device Sequence Number: 19590263
• Product Code: GAW
• UDI-Device Identifier: 10705031025592
• UDI-Public: 10705031025592
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/12/2020

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: D5636
• Device Catalogue Number: D5636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1