MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4IN 10-0 D/A CS106-6,CTC-6; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	9090G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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.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.It was reported that the "thread was cut off" and kept breaking down.Please explain what you mean by that.Did the suture break? please provide the lot number reported in this event? what is the name of the procedure? status of product return.Were there any adverse patient consequences?.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on an unknown date and suture was used.The thread was cut off while using the device.There were no adverse consequences to the patient.

• Brand Name: PRLNE BLU 4IN 10-0 D/A CS106-6,CTC-6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9119619
• Report Number: 2210968-2019-88117
• Device Sequence Number: 11465928
• Product Code: GAW
• UDI-Device Identifier: 10705031022645
• UDI-Public: 10705031022645
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/29/2019

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 Catalogue Number: 9090G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/25/2019
• Patient Sequence Number: 1