MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J426H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: what is the lot number? unknown.What is the procedure date? (b)(6) 2020.What is the event date? (b)(6) 2020.Investigation summary: it was reported dull needle.A failed suture 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.A microscope 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 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 could not 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.This medwatch report is in response to receipt of facility report mw#(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported that a patient underwent an implantation of a his bundle pacemaker procedure on (b)(6) 2020 and suture was used.During the procedure, upon suturing the pacemaker pocket, the doctor noticed the suture did not have a sharp tip.He immediately stopped suturing.He inspected the pocket for a possible suture/needle tip.He then re-opened the pocket to verify no tip was in the pocket.No tip found.He proceeded to x-ray/fluoro the pocket, as it would be visible under x-ray, no tip.The doctor proceeded to use a sterile magnet over the pocket as a further measure to ensure no tip was there, as there was not.After investigation of the pocket, it was determined there was no lost tip.The doctor opined that the needle tip may have been blunt to begin with.The suture was placed in a specimen cup and labeled.There were no patient consequences reported.No additional information was provided.Upon evaluation of the returned device, a fracture was observed at the tip of the needle.

• Brand Name: VCL CT BRD UD 27IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10331660
• Report Number: 2210968-2020-05609
• Device Sequence Number: 19695697
• Product Code: GAM
• UDI-Device Identifier: 10705031039773
• UDI-Public: 10705031039773
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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 Model Number: J426H
• Device Catalogue Number: J426H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/28/2020
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 75