MAUDE Adverse Event Report: ETHICON INC. PDSII UD 18IN 3-0 S/A PS-4 PRM MP; SUTURES - ABSORBABLE

Catalog Number	Z508G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts are being 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.
Event or Problem Description
It was reported that a patient underwent a skin graft surgery procedure on (b)(6) 2018 and a suture was used.During surgery, a needle tip was found in the patient¿s body when closing the wound by interrupted suturing.The needle tip was retrieved.There was no extension of the operation time.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Investigation summary: "it was reported performance needle breakage.A failed suture needle, was received for 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 fracture surfaces were examined via microscope and surrounding area of the needle.The evaluation 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 were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.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.".

• Brand Name: PDSII UD 18IN 3-0 S/A PS-4 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: 8219445
• Report Number: 2210968-2019-78198
• Device Sequence Number: 18884871
• Product Code: NEW
• UDI-Device Identifier: 10705031061316
• UDI-Public: 10705031061316
• 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,Followup
• Report Date (Section B): 12/06/2018

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: 01/31/2023
• Device Catalogue Number: Z508G
• Device Lot Number: MBZ092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/28/2019
• Patient Sequence Number: 1