MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 27"(70CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP219H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.The following information was requested, but unavailable: was the needle found after the procedure was completed? what tissue was the needle retained in per the ct scan? was the retained needle piece more than half of the needle? was any additional tissue dissection indicated to remove the needle? was an additional incision indicated to remove the needle piece? was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? what is the current condition of the patient? no further information.
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2017 and suture was used.The needle pulled off the suture during the procedure and after the procedure, the needle was missing.Ct test was performed to locate the needle.The procedure was prolonged 2 hours.The needle was retrieved from the patient.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # = > pc-000087161 corrected information.

• Brand Name: VICRYL PLUS SUTURE 27"(70CM) 3-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7178181
• Report Number: 2210968-2018-70169
• Device Sequence Number: 1274474
• Product Code: GAM
• UDI-Device Identifier: 10705031051720
• UDI-Public: 10705031051720
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• 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): 12/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: VCP219H
• Device Lot Number: GE6670
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention