MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 24IN(60CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8204H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been 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.Additional information was requested and the following information was obtained: was there any additional tissue damage as a result of searching for the needle piece? no further information is available.What tissue structure was it located? no further information is available.Procedure date? no further information is available.Device return status/follow up? the device has been received at sukagawa and will be shipped.Please check rmao.No further information will be provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported by a sales rep that, during an unknown plastic surgery, the needle was broken at the swage part during use.The surgeon commented that he held the needle at the swage part during suturing, and it would have caused the breakage.He also commented that, while retrieving the broken piece, he was careful so that no pieces fell into the patient¿s body.However, he requested us to confirm if there is no missing part in the retrieved pieces.The lot number is qbbbbp.Further details are not provided from the hp.When we send the sample to you, we will let you know its return date and tracking number.There were no adverse consequences to the patient.Affiliate reference number is (b)(4).
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/8/2021.Additional information: d9, h6.A manufacturing record evaluation was performed for the finished device batch qbbbbp and no non-conformances were identified.Additional h3 investigation summary: a failed suture needle was submitted for fractographic evaluation.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.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.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROLENE SUT 24IN(60CM) 4-0 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: 11158312
• Report Number: 2210968-2021-00284
• Device Sequence Number: 13622260
• Product Code: GAW
• UDI-Device Identifier: 10705031013278
• UDI-Public: 10705031013278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: No Information
• Device Expiration Date: 01/31/2025
• Device Model Number: 8204H
• Device Catalogue Number: 8204H
• Device Lot Number: QBBBBP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1