MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X36IN 4-0 D/A SH 4PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	D9060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2020
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 additional information was requested, and the following was obtained: how many devices that were involved in this single procedure? the sales rep reported 2 devices.Lot number: the lot number is unknown.Procedure name? no further information is available.Initial procedure date: no further information is available.No further information will be provided.Events were submitted via 2210968-2020-03396 and 2210968-2020-03397.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on 3/30/2020 and the suture was used.The suture broke during use.There were no patient consequences reported.

• Brand Name: PRLNE BLU 4X36IN 4-0 D/A SH 4PLGT
• 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: 9989138
• Report Number: 2210968-2020-03397
• Device Sequence Number: 3836414
• Product Code: GAW
• UDI-Device Identifier: 10705031031913
• UDI-Public: 10705031031913
• 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): 03/31/2020

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: D9060
• Device Catalogue Number: D9060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/23/2020
• Patient Sequence Number: 1