MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 18IN 4-0 S/A PS-5 PRM; SUTURE, SURGICAL, ABSORBABLE

Model Number	D8252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 was obtained: it was reported."the swage part of the needle was easy to get caught.Although other pds are not particularly concerned, the swage part of the affected product seemed to be little longer and straight" please clarify: did the needle bent, needle breakage or needle pull off from suture during the intra op event? no further information is available.Do you have a photo for visual analysis? no photos are available.Was the needle piece(s) retrieved during the same procedure? no further information is available.What tissue was being sutured when the event occurred? no further information is available.Where was the needle piece found; in what structure/tissue? no further information is available.Procedure name and date? no further information is available.Event date? no further information is available.
Event or Problem Description
It was reported that a patient underwent an unknown pediatric surgery on an unknown date and suture was used.During the procedure, it was reported that the swage part of the needle was easy to get caught.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/25/2021.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 h6 component code: g07002 reported condition not confirmed.Additional h3 investigation summary: a suture needle was submitted for fractographic evaluation.The component was identified as product code d8252.A fracture was not observed; therefore, no additional evaluation was performed.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 evaluation revealed the needle was not fractured.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/18/2021.H3 investigational narrative: a suture needle was submitted for fractographic evaluation.The component was identified as product code d8252.A fracture was not observed; therefore, no additional evaluation was performed.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 evaluation revealed the needle was not fractured.An opened sample was received to ethicon inc for evaluation.Upon visual inspection of the needle, the curvature is conforming to shadow of the finished drawing specification, however; the curve is not smooth and continuous, and the swage area seems straight and should be curved.The cosmetic appearance needle (curve is not smooth and continues) defect was observed during the visual assessment has been correlated to the manufacturing process.This product issue will be addressed through ethicon inc¿s quality system.Additional complaint information monitoring for potential safety signals will be 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.

• Brand Name: PDSII VIO 18IN 4-0 S/A PS-5 PRM
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12367037
• Report Number: 2210968-2021-07686
• Device Sequence Number: 17301447
• Product Code: NEW
• UDI-Device Identifier: 10705031029644
• UDI-Public: 10705031029644
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2021

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: 04/30/2026
• Device Model Number: D8252
• Device Catalogue Number: D8252
• Device Lot Number: REMCDL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 10/27/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/25/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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