MAUDE Adverse Event Report: ETHICON INC. PDS SUTURE 18"(45CM) 1 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D9638
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 a patient underwent a total hip arthroplasty on (b)(6) 2018 and suture was used.The suture was broken at a knot during interrupted suturing on the fascia.Another needle-suture was used for the patient.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.An empty opened foil, needle-suture pieces, a winding former with three used re-parked needles, and needle-suture combinations were returned for analysis.During the visual inspection of needle-suture piece, the swage and attachment area of needles were as expected.Marks were observed on the needles and the ends of the sutures appear to be cut from use of a surgical instrument.The other sections of the sutures were not returned.A functional test was performed, and the tensile force was above the minimum requirements.Additionally, the used needles were examined, and the swage and attachment area were as expected.Needle-sutures combinations were examined, and the swage and attachment area were as expected.The sutures were dispensed without problems and examined along the strand with no defects, damaged or suture breakage observed.A functional test was performed, and the tensile force was above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the needle-suture combinations, no breakage of suture was found on the sutures and the tested samples met the finished goods requirements.

• Brand Name: PDS SUTURE 18"(45CM) 1 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7804944
• Report Number: 2210968-2018-75321
• Device Sequence Number: 13862363
• Product Code: NEW
• UDI-Device Identifier: 10705031033917
• UDI-Public: 10705031033917
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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
• Report Date (Section B): 07/26/2018

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: 10/31/2020
• Device Catalogue Number: D9638
• Device Lot Number: JM6413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/25/2018
• Patient Sequence Number: 1