MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 30IN(75CM) 0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8424H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch pmb749, 8424h56 and no non-conformances were identified.H-3 summary: visual analysis of the returned sample determined that an unopened sample of product code 8424h was received for evaluation.Visual inspection of the unopened and no defects were found on the package.The sample was opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects or damage were observed.A functional test was performed using an instron and the pull force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted and the actual complaint sample was not returned for analysis.Additional information was requested, and the following was obtained: what was the name of the procedure?- hernia repair was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain- no.Did the suture break or did the suture separated from the needle?- suture separated from the needle only.In case of suture breakage: n/a.What tissue was being approximated or sutured when it broke? did the suture separate completely? could you please provide status of the product return?- will return it.
Event or Problem Description
It was reported that the patient underwent a hernia repair on (b)(6) 2021 and the suture was used.During surgery, the suture separated from the needle only.As a result, a new suture was opened, and this caused delay to procedure.No adverse event or patient consequence resulted from this.Procedure was completed successfully with a ten minutes delay.

• Brand Name: PROLENE SUT 30IN(75CM) 0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11953382
• Report Number: 2210968-2021-05340
• Device Sequence Number: 4403860
• Product Code: GAW
• UDI-Device Identifier: 10705031015449
• UDI-Public: 10705031015449
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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: 10/31/2024
• Device Model Number: 8424H
• Device Catalogue Number: 8424H
• Device Lot Number: PMB749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/07/2021
• Patient Sequence Number: 1