MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8756H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
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 a later date a supplemental medwatch will be sent.The single complaint was reported with multiple events.Additional information was requested and the following was obtained: lot #? code 8756h¿>peh313.Confirm the specific number of devices (total qty actually involved with reported issue) that failed during this event /procedure for each product code/lot? exact quantities unknown, surgeon said at least a couple sutures/code was procedure completed successfully? case was completed successfully any patient consequence? no patient consequences.Note: events reported via 2210968-2019-91088, 2210968-2019-91089, 2210968-2019-91090.
Event or Problem Description
It was reported that the patient underwent a vascular procedure on an unknown date and suture was used.During the procedure, the needle was popping off.The surgeons tried several different packages of each code and still had the same problem.The surgeons were able to complete the procedure but took a bit longer because the needles kept popping off.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/24/2020.A manufacturing record evaluation was performed for the finished device batch peh313, 8756h56 and no non-conformances were identified.Additional h3 investigation summary: one picture was provided for analysis.Upon visual inspection of the photo, sixteen needle-sutures and two needles of unknown product code could be observed.The two needles appear to be detached and two of the needle-suture pieces were bent.No conclusion could be reach as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: PROLENE SUTURE 18"(45CM) 5-0 BLU
• 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: 9491043
• Report Number: 2210968-2019-91087
• Device Sequence Number: 18906346
• Product Code: GAW
• UDI-Device Identifier: 10705031020252
• UDI-Public: 10705031020252
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/26/2019

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: 04/30/2024
• Device Model Number: 8756H
• Device Catalogue Number: 8756H
• Device Lot Number: PEH313
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1