MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 4X30IN 2 S/A V-37; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	MX69G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2019
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.Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch number: batch pch822.
Event or Problem Description
It was reported that a patient underwent an unknown orthopedic surgery on (b)(6) 2019 and suture was used.During the procedure, the suture was broken when tying during interrupted suturing.The surgeon commented that no extra force was applied.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch number: batch pch822, mfg.Date 03/14/2019, exp.Date 02/29/2024.In addition, a review of the manufacturing record evaluation for the possible batch number was performed for the finished device lot, and no non-conformances were identified.Additional: it was reported performance breakage suture.A needle/suture pieces of product code mx69g, lot # pch822 was returned for analysis.During the visual inspection of the sample, the swage and attachment area were noted to be as expected and marks on body by use of a surgical instrument could be observed.The suture was observed broken do the stress applied to the strand, present damaged on the surface and the end.Appears to be by use of a surgical instrument.No functional test could be performed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause of the performance breakage suture was an improper handling.

• Brand Name: EB EXC GRN 4X30IN 2 S/A V-37
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9165775
• Report Number: 2210968-2019-88439
• Device Sequence Number: 14363207
• Product Code: GAT
• UDI-Device Identifier: 10705031047150
• UDI-Public: 10705031047150
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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): 09/11/2019

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: MX69G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/12/2019
• Patient Sequence Number: 1