MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 8"(20CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	D6885
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.
Event or Problem Description
It was reported that a patient underwent a bilateral tarsal strip procedure on (b)(6) 2019 and suture was used.The sutures were fraying when straightening out.A similar device was used to complete the case.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pdz879 number, and no non-conformances were identified.It was received for analysis four empty labeled winding former and five dispensed needle-sutures combination of product code d6885, lot pdz879.During the visual inspection of the dispensed needles-sutures, the swage and attachment area of the needle were noted to be as expected; but, the suture present filaments, fraying suture and damaged along of strand.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.No conclusion could be reached as to what may have caused the reported incident.It was received for analysis unopened samples of product code d6885, lot pdz879.During the visual inspection of unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problem and examined, no defects, damage or fraying suture along of the strands were observed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance ¿ fraying suture intra-op was found.

• Brand Name: PROLENE SUTURE 8"(20CM) 4-0 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: 9343907
• Report Number: 2210968-2019-90100
• Device Sequence Number: 2739777
• Product Code: GAW
• UDI-Device Identifier: 10705031026919
• UDI-Public: 10705031026919
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: 03/31/2024
• Device Catalogue Number: D6885
• Device Lot Number: PDZ879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/06/2019
• Patient Sequence Number: 1