MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X30IN 6-0 D/A BV-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8709
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).Investigation summary: returned product : visual analysis of the returned product revealed that one empty overwrap packet and two sutures pieces of product code m8709 were received to ethicon inc for evaluation.Upon visual inspection of the returned sample, the suture was received in two sections, damages at the surface and the ends were observed broken due to stress applied.After further evaluation crimping marks were observed on the surface suture possibly from a surgical instrument.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.,according to the information received, the sutures were breaking during use.Returned product : visual analysis of the returned product revealed that one empty overwrap packet and two sutures pieces of product code m8709 were received to ethicon inc for evaluation.Upon visual inspection of the returned sample, the suture was received in two sections, damages at the surface and the ends were observed broken due to stress applied.After further evaluation crimping marks were observed on the surface suture possibly from a surgical instrument.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.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.,according to the information received, the sutures were breaking during use.Representative sample: seven packets of product code m8709 were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the packets.The product code is multistrand and each packet contains four strands double armed.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand to detect any issue related to damaged or breakage suture and no defects were observed during evaluation.Functional test was performed, and the tensile strength result were above the minimum requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot number and no non-conformance related to the reported complaint condition were identified.Additional information was requested, and the following was obtained: unfortunately the staff is unable to give me specific information.But, this is what i have gathered.They said multiple strands were breaking, especially during tying.The sutures were breaking mid strand, not separating at the swage.They saved some of the sutures, but didn¿t recall how many.They packaged these sutures in a specimen cup and also included some unused sutures from the same lot number.The staff is concerned because they have had several incidents with this same lot number.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: 2 used sutures were received.Please confirm how many sutures broke during one procedure.
Event or Problem Description
It was reported that a patient underwent a carotid procedure on (b)(6) 2021 and suture was used.During the procedure, the suture broke.It is unknown where the sutures were breaking.There were no patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 4X30IN 6-0 D/A BV-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13031950
• Report Number: 2210968-2021-12729
• Device Sequence Number: 4451608
• Product Code: GAW
• UDI-Device Identifier: 10705031045835
• UDI-Public: 10705031045835
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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: 06/17/2021
• Device Model Number: M8709
• Device Catalogue Number: M8709
• Device Lot Number: RGBDSC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown