MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 2-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y266H
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture reverse cutting needle was different than it used to be.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 6/6/2023.H6 component code: g07002 - pending evaluation of returned device.A device has been received for product code y266h, lot tamcqr, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, the following was obtained: 1.How many devices have this issue? at the time of surgery when dr.(b)(6) noticed the difference in the needle type on suture from lot#: smmdpz, she had the or nurse, amie, open another pack of y266h from a different lot #: spmcux finding the same difference in the needle.Dr.(b)(6) then had amie open up a 3-0 monocryl (y942) and a o monocryl (y967) to see what those reverse cutting needles looked like.Both had the correct reverse cutting needle that she (dr.(b)(6)) expected to see on the suture in question but did not.We have included all these packs so that they could be looked at and compared at your facility.2.Yes.There are 4 different lot numbers (smmdpz, spmcux, spmbdu and tamcqr) at our facility that currently have this issue.3.To confirm how many packages had the issue from each lot number that information is as follows: a.1 pack opened and tried to use for surgery when needle was noticed to be different lot #smmdpz (no more packs of this lot in our clinic) b.2 packs opened and not used from lot #spmcux (no more packs of this lot in our clinic) c.1 pack opened for comparison lot #spmbdu (we have 2 boxes of this unopened packs in our clinic) d.1 pack opened for comparison lot #tamcqr (we have 5 boxes of this unopened packs in our clinic) 4.I am also sending back the 2 opened packs of 3-0 monocryl and 0 monocryl that were used as comparison and have the type of reverse cutting needles we are used to having.5.The name of the person providing these answers to questions is myself: (b)(6) (all contact information within this email) questions from the actual surgery where the difference was notice should be directed to the surgeon, dr.(b)(6) (she is copied in this email as is the or nurse, amie fetterman) 6.Device return status: the shipment tracking number is as follows: fed ex 6426 8136 9173 pick up called for today 5-19-2023 by (b)(6).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, or its employees that the report constitutes an admission that the product, ethicon, 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.Related reports: 2210968-2023-03708, 2210968-2023-03709, 2210968-2023-04085, & 2210968-2023-04086.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned devices.The returned sample revealed that it was received one sample that pertain to product code y266h, lot tamcqr.Also, it was one suture 3-0 monocryl product code y942h, lot semeqh, and a 0 monocryl product code y967h, lot scmhba.Upon visually inspecting the returned samples, a comparison was made between the needles.It was noticed that a variation in the body shape of the needles.The body needles of product code y266 are not triangular in shape.The needle rmc assigned to these lots numbers and product codes contains the same characteristics to body geometry: triangular and data specification drilled cutting edge reverse triangular ribbed.Based on the information currently available, an incorrect finish issue was identified during the investigation of the sample received.This product issue will be addressed through the quality system.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 2-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17071242
• Report Number: 2210968-2023-04084
• Device Sequence Number: 17613886
• Product Code: GAN
• UDI-Device Identifier: 10705031058637
• UDI-Public: 10705031058637
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• 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,Followup
• Report Date (Section B): 06/30/2023

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 Model Number: Y266H
• Device Catalogue Number: Y266H
• Device Lot Number: TAMCQR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown