MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN 0 S/A CTB CR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDPB750D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Attempts are being 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 orthopedic surgery on (b)(6) 2019 and the suture was used.It was reported that during surgery, the needle easily detached from the suture during use.It was a control release needle.The surgeon stopped using the rest of needles in the package, and another package was used for the patient.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Date sent to the fda: 02/05/2020.
Additional Manufacturer Narrative
Date sent to the fda: 02/05/2020.Additional information: d10, h6.Additional h-3 summary: one open sample of product was received for analysis.The product code is control release and required eight strands per packet.During visual inspection of detached needle, the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined and no suture remnant was observed; the insertion of suture was observed to be as expected.The force used to detach needle from the suture could not be determined.Also, the three used needles were examined, and the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined, and no suture remnant was observed; however, slight mark that appears to be by use of surgical instrument were found.Additionally, three needle-suture combination were visually inspected, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed using an instron and the pull force were above the minimum requirements.Per the condition of detached needle-suture, it could not be could not be determined what may have caused the reported incident of: ¿the needle was detached from the suture easily during use¿.

• Brand Name: PDS PLUS VIO 8X18IN 0 S/A CTB CR
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9517961
• Report Number: 2210968-2019-91289
• Device Sequence Number: 2649375
• Product Code: NEW
• UDI-Device Identifier: 10705031218833
• UDI-Public: 10705031218833
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• 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): 12/04/2019

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: 06/30/2021
• Device Catalogue Number: PDPB750D
• Device Lot Number: PHZ697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/15/2020; 01/15/2020
• Initial Report FDA Received Date: 12/25/2019
• Supplement Report FDA Received Date: 02/05/2020; 02/05/2020
• Patient Sequence Number: 1