MAUDE Adverse Event Report: ETHICON INC. PRLNE CLR 18IN 4-0 S/A PS-4 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8603G
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).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.What was the initial procedure? what is the event day and procedure date? what is the lot number? 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date; and a suture was used.During the procedure, the suture and needle separated.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PRLNE CLR 18IN 4-0 S/A PS-4 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10705511
• Report Number: 2210968-2020-08140
• Device Sequence Number: 14180369
• Product Code: GAW
• UDI-Device Identifier: 10705031017603
• UDI-Public: 10705031017603
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K133356
• 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): 10/05/2020

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: 8603G
• Device Catalogue Number: 8603G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1