MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 36IN 2-0 D/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	D6432
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts to obtain the following information has been performed and the following was received.If the further details are received at a later date a supplemental medwatch will be sent were x-rays taken to locate the needle piece(s)? no further information is available.Was the needle piece(s) retrieved during the same procedure? no further information is available.Does a piece of the needle remain in the patient¿s tissue? no further information is available.What tissue structure is it located? size of the needle piece retained? no further information is available.Was there any additional tissue damage as a result of searching for the needle piece? no further information is available.No further information will be provided.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported a patient underwent an unknown surgery on unknown date and a suture was used.The needle was broken at the swage part.The lot number is unknown.Further details are not provided.No sample will be returned.There were no adverse consequences to the patient.

• Brand Name: VCL CT BRD UD 36IN 2-0 D/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9941684
• Report Number: 2210968-2020-02810
• Device Sequence Number: 16685443
• Product Code: GAM
• UDI-Device Identifier: 10705031026391
• UDI-Public: 10705031026391
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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
• Report Date (Section B): 03/13/2020

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: Health Professional
• Device Model Number: D6432
• Device Catalogue Number: D6432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1