MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 27IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP427H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint(b)(4).Date sent to fda: 5/13/2024.H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Additional information was requested, and the following was obtained via: * did a piece of the broken needle fall into the patient? if so, was it retrieved? ¿ yes, the needle broke off into patient & was visibly retrieved.* what was done to retrieve/search for the broken piece? ¿ magent was used to locate & retrieve the broken piece.* please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) ¿ rosario rottenberg, clinical lead rep called to provide that a second device for the same product was used that had a similar issue to the first device reporting.Facility was unsure which lot number it was associated with so she provided three of them with the expiration date.She will send back the device within the same box as the first one: tdmetq 3/31/2028 tlmasb 9/30/2028 tlmetq 3/31/2028 additional information was requested, the following was obtained: a device was received for product code y303h lot#tdmetq.However, lots tlmasb and tlmetq were previously reported.Please confirm if product code y303h lot tdmetq, y303h lot tlmasb and product code vcp753d lot tlmetq belongs to this complaint.Did needle breakage occur during the same procedure for all three lots? the event happened on 2 different occasions on 2 separate days.Please see information below.From the customer: we had a suture needle break during a case yesterday.We were able to locate the broken piece and retrieve the complete needle.This are the specifics of the suture that failed: 3-0 monocryl ps-2, mcp 427, ccn: wjmcp427.A30 unfortunately i do not have lot # or expiration date as the outer packaging had already been discarded.I will hold on to the suture until i¿m able to hand it over to you for evaluation (product sent in for evaluation) from the customer: we had another suture failure during dr.Mcginn¿s case yesterday.Same situation as last time she the needle snapped at roughly the same place as in the previous event.Both of these events have occurred when going through very soft tissue (fat in one instance).We were able to retrieve all parts of the needle.Suture info: 5-0 monocryl rb-1, y303.As we had multiple packets of this suture open it could be from one of the following lot #s: tdmetq exp.3/31/2028 tlmasb exp.9/30/2028 tlmetq exp.3/31/2028 related reports: 2210968-2024-04789 & 2210968-2024-05334.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle broke in half.The event occurred when going through very soft tissue.They were able to retrieve all parts of the needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/14/2024.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3 investigational summary: the product received for analysis was identified as product code mcp427h.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the suture attachment of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.The needle was noted with marks that appears to be by surgical instrument.A scanning electron microscope was used to examine the fracture surface and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of the sample revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: MCRYL+ UD 27IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19299297
• Report Number: 2210968-2024-05334
• Device Sequence Number: 17858792
• Product Code: GAM
• UDI-Device Identifier: 10705031046511
• UDI-Public: 10705031046511
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: MCP427H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown