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

Model Number	Z317H
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
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot number qpmhsq/z317w33 and no non-conformance's related to the reported complaint condition were identified.Summary: upon visual inspection of the one opened sample received for evaluation of product code z317h, it was observed the needle was broken at the swage area and a part of the needle still was attached to suture.The sample needs additional evaluation: hsa analysis: a failed suture needle was submitted for fractographic evaluation.The component was identified as product code z31h.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.The evaluation 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.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on unknown date and the suture was used.The product was not used on the patient.Upon evaluation, a fracture was observed at the suture attachment of the needle.There were no patient consequences reported.

• Brand Name: PDSII VIO 27IN 2-0 S/A SH
• 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; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12816361
• Report Number: 2210968-2021-11456
• Device Sequence Number: 14839793
• Product Code: NEW
• UDI-Device Identifier: 10705031060494
• UDI-Public: 10705031060494
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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: 11/30/2025
• Device Model Number: Z317H
• Device Catalogue Number: Z317H
• Device Lot Number: QPMHSQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown