MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8629H
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).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported that the device had a pull off - suture needle issue.Twenty-two unopened samples of product code 8629, lot mgh230 were returned for analysis.The complaint sample was not received or evaluation.During the visual inspection of twenty-two 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 problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were 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 samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.
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 came off the needle.It is unknown how the case was completed.There were no patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 08/27/2019.H3 device evaluation summary: three unopened samples of product code 8629, lot mgh230 were returned for analysis.The complaint sample was not received or evaluation.During the visual inspection of three unopened samples, no defects were observed on the packets.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were examined along of strand and no defects or damaged were noted.Functional test was performed on the samples and the pull force of the samples did not meet the minimum ltl requirement due to clip off defect.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, the assignable cause of performance - pull off suture needle pre-op is a clip off defect, this defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.

• Brand Name: PROLENE SUTURE 18"(45CM) 4-0 BLU
• 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: 8862397
• Report Number: 2210968-2019-85166
• Device Sequence Number: 1829146
• Product Code: GAW
• UDI-Device Identifier: 10705031018044
• UDI-Public: 10705031018044
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: 05/31/2023
• Device Catalogue Number: 8629H
• Device Lot Number: MGH230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/27/2019
• Patient Sequence Number: 1