MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 6-0 D/A CC175-8 MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	W8807
Medical Device Problem Code	Material Separation (1562)
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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture was easily detached from the needle.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 09/20/2019.Additional h3 investigation summary: an empty opened overwrap packet, a labeled winding former with a detached needle and a needle/suture tangled of product code w8807, lot # mlh519 were returned for analysis.During the visual inspection of a detached needle, the swage and attachment area present damage and marks by use of a surgical instrument, and the edge of the barrel hole could be observed flat.The end of the suture was observed cut and damaged appear to be by use of a surgical instrument.Per the condition of the sample received, the assignable cause of the pull off suture needle is an improper handling.

• Brand Name: PRLNE BLU 24IN 6-0 D/A CC175-8 MP
• 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: 8891200
• Report Number: 2210968-2019-85515
• Device Sequence Number: 16777664
• Product Code: GAW
• UDI-Device Identifier: 10705031231719
• UDI-Public: 10705031231719
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup,Followup
• Report Date (Section B): 07/17/2019

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: 09/30/2023
• Device Catalogue Number: W8807
• Device Lot Number: MLH519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 08/26/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/14/2019; 09/20/2019
• Patient Sequence Number: 1