MAUDE Adverse Event Report: ETHICON INC. PDSII UD 27IN 2-0 S/A PS-8 PRM MP; SUTURES - ABSORBABLE

Catalog Number	Z515G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A failed suture needle, labeled as (b)(4), identified as product code z515g was returned for evaluation.A fracture was observed at the tip of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.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 in order to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The manufacturing records couldn't be reviewed as the batch number is unknown.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.
Event or Problem Description
It was reported that the patient underwent an unknown cardiovascular procedure on (b)(6) 2019 and suture was used.During the procedure, the needle tip was bent and it was almost broken during use.Upon evaluation of the device, a fracture was observed at the tip of the needle.There were no adverse consequences to the patient.

• Brand Name: PDSII UD 27IN 2-0 S/A PS-8 PRM MP
• Common Device Name: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8546330
• Report Number: 2210968-2019-80688
• Device Sequence Number: 16236666
• Product Code: NEW
• UDI-Device Identifier: 10705031061378
• UDI-Public: 10705031061378
• 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): 03/28/2019

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: Z515G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1