MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 27IN 4-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z422H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/12/2023.H6 component code: g07002 - device not returned.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.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Attempts are being 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.
Event or Problem Description
It was reported that a patient underwent a laparoscopic cholecystectomy procedure on an unknown date and suture was used.During the laparoscopic cholecystectomy procedure, the needle was detached from the suture when putting the first stitch.It was not a control release needle.There were no adverse consequences to the patient.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/21/2023.H3 investigational summary: the product received for analysis was identified as product code z422h.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the suture attachment of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.The needle was noted with marks that appears to be by surgical instrument.A scanning electron 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 of sample revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/21/2023.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned devices.The returned samples determined that one empty foil, one empty labeled winding former and one detached needle that pertain to product code z422.In order to evaluate the condition of the returned sample, it was observed that the needle was broken at the swage area.In addition, the broken needle will be shipped to hsa for further analysis due to the needle breakage.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.No conclusion could be reached due to the sample needs additional evaluation by hsa.As part of the 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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Needle investigation summary: the product received for analysis was identified as product code z422h.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the suture attachment of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.The needle was noted with marks that appears to be by surgical instrument.A scanning electron microscope (sem) 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 of sample revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.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.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The needle breakage was confirmed.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: PDSII CLR 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; col salvacar; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16921054
• Report Number: 2210968-2023-03554
• Device Sequence Number: 15154737
• Product Code: NEW
• UDI-Device Identifier: 10705031060890
• UDI-Public: 10705031060890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/20/2023

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: Z422H
• Device Catalogue Number: Z422H
• Device Lot Number: SMMCMU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/02/2023; 07/14/2023; 10/19/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/21/2023; 07/21/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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