MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 36"(90CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z346H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.A manufacturing record evaluation was performed for the finished device number, and no non-conformance were identified.This medwatch report is in response to receipt of maude event report mw5084711.
Event or Problem Description
It was reported via maude report that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The needle broke during use.It was not reported if the tip was retrieved.It was not reported how the procedure was completed.There were no adverse consequences to the patient reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: the actual device was received for analysis.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 fracture surfaces were microscopically examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.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.The needle breakage was confirmed.A manufacturing record evaluation was performed for the finished device mdm263 number, and no non-conformances were identified.

• Brand Name: PDS II SUTURE 36"(90CM) 0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8515868
• Report Number: 2210968-2019-80376
• Device Sequence Number: 2675665
• Product Code: NEW
• UDI-Device Identifier: 10705031060661
• UDI-Public: 10705031060661
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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 Expiration Date: 03/31/2023
• Device Catalogue Number: Z346H
• Device Lot Number: MDM263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/13/2019
• Patient Sequence Number: 1