MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 5-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	X556H
Medical Device Problem Code	Material Separation (1562)
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) h6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: i have some updated information from cook to be added to the complaint.They have confirmed the needles are falling of the sutures when they open the packet.As well as during the sewing process which cause rework for the operator (b)(6) the snr procurement manager has advised the following codes in red are impacted.It indicates in red the number of sutures by lot number.Cpn approved date rm id mfg lot boxes of 36 eaches needles detached qty percentage of fault x556h mar-24 z0324-180 tpmbud 61 2196, z0324-181 tpmcqj 72 2592, z0324-182 tpmezz 78 2808, z0324-183 tpmhjp 71 2556, z0324-184 tpmjex 87 3132, z0324-185 uambuz 125 4500, feb-24 z0224-674 tpmhjp 6 216, jan-24 z0124-396 tmmckr 36 1296 1 0.1%, z0124-397 tmmdad 17 612, z0124-398 tmmdae 36 1296 3 0.2%, z0124-399 tmmdbh 48 1728, z0124-645 tmmdae 3 108, z0124-661 tmmdbh 15 540, z0124-662 tmmhrc 12 432, z0124-663 tmmhrc 34 1224, z0124-664 tmmhmx 72 2592, z0124-665 tmmckr 25 900, z0124-666 tmmdad 40 1440 6 0.4%, z0124-667 tmmdae 36 1296 19 1.5%, z0124-668 tmmdbh 2 72, z0124-684 qjmhpt 1 36, z0124-685 rlmauc 19 684, z0124-686 tmmdbh 13 468, z0124-687 tmmhhj 76 2736 1 0.0%, z0124-688 tmmhmx 11 396, z0124-689 tmmhrc 22 792, z0124-772 tpmcqj 3 108, z0124-773 tpmbud 8 288, dec-23 z1223-670 tlmrtb 76 2736, z1223-690 tmmdad 19 684 4 0.6%, nov-23 z1123-109 tdmcah 37 1332, z1123-110 temquh 48 1728, z1123-112 temmxz 24 864, z1123-113 temdcr 36 1296, z1123-114 tembel 30 1080, z1123-115 temars 36 1296, z1123-116 tummuq 33 1188, z1123-117 tdmlhk 54 1944, z1123-449 temars 44 1584, z1123-450 tembel 48 1728, z1123-451 temdcr 42 1512, z1123-452 temmxz 38 1368, z1123-453 temqhu 30 1080, oct-23 z1023-601 tdmmtd 78 2808, z1023-602 tdmcah 38 1368, z1023-603 tcmklk 1 36, sep-23 z0923-506 tamkrd 14 504, z0923-507 tcmklk 32 1152, z0923-508 tcmrue 7 252, z0923-509 tdmade 29 1044, z0923-510 tdmlau 95 3420, z0923-511 tdmlhk 36 1296, z0923-512 tdmmhs 78 2808, z0923-513 tdmmuq 46 1656, z0923-514 tdmqas 78 2808, aug-23 z0823-408 rgmcus 6 216, z0823-409 rlmkmp 3 108, z0823-410 rmmqtt 10 360, z0823-411 samrlx 3 108, z0823-412 shmecb 6 216, z0823-413 shmqlb 5 180, z0823-414 tamkrd 144 5184, z0823-415 tbmpsq 78 2808, z0823-416 tcmklk 0 0, z0823-417 tcmkqq 38 1368, z0823-418 tcmlmz 38 1368, z0823-419 tcmltr 5 180, z0823-420 tcmqkx 36 1296.The cook medical team are also testing other lot numbers to see if they are impacted and will advise.I have also advised our regional wound closure marketing manager.The manufacturing records could not be reviewed as the batch/lot number is unknown.D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2024 and suture was used.During the procedure, supplier quality engineer team lead reported that the needle is detaching from the suture.There were no adverse consequences reported.Additional information was requested.

• Brand Name: EB EXC GRN 36IN 5-0 D/A RB-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 20908767
• Report Number: 2210968-2024-13305
• Device Sequence Number: 12718912
• Product Code: GAT
• UDI-Device Identifier: 10705031057555
• UDI-Public: 10705031057555
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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: X556H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown