MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 5-0 S/A PS-2 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8686G
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 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.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.After the patient returned with the broken sutures, was there any medical or surgical intervention performed? was the patient re-sutured? what part of the body were the sutures being used on? what is the current status of the patient?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used for a laceration.After procedure was completed, the patient returned within the hour with all stitches broken across the middle of the wound.There were no adverse patient consequences.Additional information has been received.
Additional Manufacturer Narrative
Date sent to the fda: 02/05/2020.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.

• Brand Name: PRLNE BLU 18IN 5-0 S/A PS-2 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: 9341376
• Report Number: 2210968-2019-90084
• Device Sequence Number: 2739647
• Product Code: GAW
• UDI-Device Identifier: 10705031019003
• UDI-Public: 10705031019003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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 Expiration Date: 02/29/2024
• Device Model Number: 8686G
• Device Catalogue Number: 8686G
• Device Lot Number: PCH944
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1