MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 7-0 D/A BV175-7 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8766
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number php889, and no non-conformances were identified.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 (b)(6) 2019 and suture was used.The needle was unexpectedly disconnecting from suture.A similar device from a different lot was used to complete the case.There were no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/24/2020.Additional information: h3 evaluation: one unopened sample of product was received for analysis.The product code is multi-strand and contains two strands double armed per packet.During the visual inspection of the unopened sample, no defects were observed on the packet.The sample was opened, and all contains two strands double armed.The swage and attachment area of the needle-sutures combinations were noted to be as expected.The sutures were dispensed and examined along strand with no defects or damages found.The functional test was performed and the pull force average did not meet requirement.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample, the assignable cause is needle pull off due to light swage.

• Brand Name: PRLNE BLU 2X24IN 7-0 D/A BV175-7 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: 9510659
• Report Number: 2210968-2019-91227
• Device Sequence Number: 13838603
• Product Code: GAW
• UDI-Device Identifier: 10705031046160
• UDI-Public: 10705031046160
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: M8766
• Device Catalogue Number: M8766
• Device Lot Number: PHP889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1