MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 2-0 S/A CT-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8423H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: component code: g07002 - device not returned.Additional information provided: around 6 strands of suture had their needle pop off when passing through the robotic 8mm trocar.Dr.Claimed that the needle has never popped off in the past.Was surgery delayed due to the reported event?: unknown, action taken when event occurred?: another strand of prolene was opened and used, was procedure successfully completed?: yes, were fragments generated?: unknown, if yes, were they removed easily without additional intervention?: unknown, patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.It was reported surgeon had 6 prolene sutures 8423h of lot: tlbhjc pulled off during robotic procedure.However, what was received does not match, 11 suture products were received: lot tlbhjc 1 needle and one suture -as reported lot tjbhtz 3 needles and 3 sutures lot thbdld 4 needles and 3 sutures 1 needle suture piece that appears to be stratafix spiral undyed 2 needles suture pieces that are not ethicon product (code vl0cl0346).Please clarify if these are sutures that had the needle pull off during this patient procedure? please clarify if we may replace 5 of the 6 reported with lot tlbhjc with the lots received (tjbhtz & thbdld ) and also to add the additional samples as pulling off (stratafix spiral)? lastly, please ask the customer if they would like to receive the 2 needles suture pieces that are not ethicon product (code vl0cl0346).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.
Event or Problem Description
It was reported a patient underwent a robotic ventral hernia repair on an unknown date in 2024 and suture was used.Strand of suture had the needle pop off when passing through the robotic 8mm trocar.New one was used to complete the procedure without patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint (b)(4).Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Please clarify if these are sutures that had the needle pull off during this patient procedure? every strand of prolene included in the product returned, regardless of lot number, was likely part of the product complaint.Please clarify if we may replace 5 of the 6 reported with lot tlbhjc with the lots received (tjbhtz & thbdld ) you may replace 5 of the 6 reported with lot #tlbhjc with lots tjbhtz and thbdld.And also to add the additional samples as pulling off (stratafix spiral)? please ignore the stratafix and v-loc strands that were included.Lastly, please ask the customer if they would like to receive the 2 needles suture pieces that are not ethicon product (code vl0cl0346).No need to send back the v-loc strands.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.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.
Additional Manufacturer Narrative
Product complaint #(b)(4).H3 evaluation: the product was returned for evaluation.One detached needle and one suture tangled in a winding former that pertained to product code was returned.During the visual inspection of the detached needle, the swage and attachment area were noted with a light swage.The barrel hole was examined under magnification for suture remnant, and none was observed.The suture end was examined and there isn¿t sufficient impression at the insertion mark.Based on the information currently available, iight swage issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the quality system.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.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.

• Brand Name: PRLNE BLU 30IN 2-0 S/A CT-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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19449090
• Report Number: 2210968-2024-05717
• Device Sequence Number: 14272357
• Product Code: GAW
• UDI-Device Identifier: 10705031015418
• UDI-Public: 10705031015418
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 07/02/2024

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 Catalogue Number: 8423H
• Device Lot Number: TJBHTZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/03/2024; 06/03/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/27/2024; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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