MAUDE Adverse Event Report: ETHICON INC. PRONOVA SUTURE 24"(60CM) 6-0 BLU; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	M3805
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Specific number of procedures did the needles pull off, for each procedure, event date, specific number of affected devices, lot number, how was case completed? contact person name, facility name, facility mailing address, and telephone number where is shipper kit can be mailed to help in return of the product for analysis and to ship a replacement order.Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.
Event or Problem Description
It was that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle popped off the suture.It was not reported how much suture was used in the case.There were no patient consequences reported.Additional information has been requested.

• Brand Name: PRONOVA SUTURE 24"(60CM) 6-0 BLU
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8703791
• Report Number: 2210968-2019-82792
• Device Sequence Number: 19331000
• Product Code: GAW
• UDI-Device Identifier: 10705031045293
• UDI-Public: 10705031045293
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

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: M3805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/17/2019
• Patient Sequence Number: 1