MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8580H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the patient underwent an unknown surgery on (b)(6) 2020 and suture was used.The suture was torn during the reconstruction of the internal iliac bone with a stent graft.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/17/2020.A manufacturing record evaluation was performed for the finished device lot number mgr853 and no non-conformances were identified additional h3 investigation summary: two empty ovwerwrap, two labeled winding former and one suture in two sections of product code 8580, lot mrg853 were received for analysis.During visual inspection of the two suture pieces, damaged on the surfaces, elongation and one extreme with a linear cut could be observed in both suture piece.In addition, due to the condition of the sample the functional test can¿t be performed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.

• Brand Name: PROLENE SUTURE 36"(90CM) 5-0 BLU
• 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: 10103121
• Report Number: 2210968-2020-04262
• Device Sequence Number: 2471769
• Product Code: GAW
• UDI-Device Identifier: 10705031017337
• UDI-Public: 10705031017337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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): 05/20/2020

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 Model Number: 8580H
• Device Catalogue Number: 8580H
• Device Lot Number: MGR853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/17/2020
• Patient Sequence Number: 1