MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8699G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number (b)(4) , and no non-conformances were identified.The product upon which this medwatch is based has been received.However, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that the patient underwent a cyst excision surgery on (b)(6) 2019 and suture was used.The suture broke while suturing during surgery.Changed to another device to complete the procedure.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device evaluation summary - actual: one empty labeled winding former and a needle-suture in two sections of product code 8699, lot pah392 were received for analysis.During the visual inspection of the opened sample (needle/suture piece), the swage and attachment area were noted to be as expected.However, the suture was observed detached do the stress applied to the strand.Also, the other section of the suture present elongation.In addition, a functional test was performed and the tensile strength force was above the minimum requirement.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.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.H3 device evaluation summary - representative samples: one empty opened box and ten unopened samples of product code 8699, lot pah392 were received for analysis.During the visual inspection of ten 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 strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile strength force was above the minimum requirement.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, no performance - breakage suture was found and the tested samples met the finished goods requirements.Representative samples returned to support investigation of 2 device issues captured in reports 2210968-2019-89182.Analysis results have been included in follow up reports for each.

• Brand Name: PRLNE BLU 18IN 4-0 S/A P-3 PRM MP
• 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: 9255078
• Report Number: 2210968-2019-89183
• Device Sequence Number: 14393641
• Product Code: GAW
• UDI-Device Identifier: 10705031019263
• UDI-Public: 10705031019263
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 12/31/2023
• Device Catalogue Number: 8699G
• Device Lot Number: PAH392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/15/2019
• Patient Sequence Number: 1