MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 3-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J864D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify the intra-op event: what does it mean the suture ¿tip of the needle broke off when using the suture¿? was this needle breakage or pull off (detached from the needle)? please confirm that the needle piece was removed from the patient during the same procedure? were x-rays taken to locate the needle? what tissue/location was suturing when needle broke or pull off occurred? were there any unexpected outcomes or complications as a result of ¿tip of the needle broke off when using the suture¿during the intra op event? procedure name? lot number? device return status/follow up?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the tip of the suture broke off.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VCL CT BRD UD 8X18IN 3-0 S/A SH CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10962376
• Report Number: 2210968-2020-09663
• Device Sequence Number: 13599261
• Product Code: GAM
• UDI-Device Identifier: 10705031000278
• UDI-Public: 10705031000278
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

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: No Information
• Device Model Number: J864D
• Device Catalogue Number: J864D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/07/2020
• Patient Sequence Number: 1