MAUDE Adverse Event Report: ETHICON INC. PDSII UD 18IN 4-0 S/A PS-5 PRM MP; SUTURES - ABSORBABLE

Catalog Number	Z594G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigative summary: one empty labeled winding former and one used needle-suture combination of product code z594 were returned for analysis.During visual inspection of the needle, the closure of the channel was noted to be as expected.The needle was comparison with the needle specification and the needle fall outside of curve tolerance shadow line,resulting in incorrect curvature.In addition marks due to use could be observed.Additionally, the tip of the needle was broken and the assignable cause cannot be concluded.A further evaluation is necessary.The manufacturing records could not be reviewed as the batch number is unknown.Per the sample condition the assignable cause is incorrect curvature.Additional evaluation: a needle was submitted for fractographic evaluation.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.The evaluation of revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage, a cup-and-cone shaped fracture and macroscopic plastic deformation observed coincidental to the fracture provide additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the tip 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 a patient underwent an unknown plastic surgery on an unknown date and suture was used.During the procedure, the needle bent.The surgeon stopped using the needle-suture.There were no adverse consequences to the patient.Upon evaluation of the returned device, the tip of the needle was broken.No additional information was provided.

• Brand Name: PDSII UD 18IN 4-0 S/A PS-5 PRM MP
• Common Device Name: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9780460
• Report Number: 2210968-2020-01685
• Device Sequence Number: 2649794
• Product Code: NEW
• UDI-Device Identifier: 10705031061477
• UDI-Public: 10705031061477
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2020

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: Z594G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1