MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP494G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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.Additional information was requested and the following was obtained: how long was the delay? unknown.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? unknown.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain.No.Name of the procedure? unknown.This medwatch report is in response to receipt of facility report # 0733000000-2019-8053.(b)(4).
Event or Problem Description
It was reported that a patient underwent an unknown procedure in (b)(6) 2019 and suture was used on the skin.During the procedure, the suture was being used to suture skin and a majority of the needle broke off under the skin.Part of the needle was still on the suture.Closing was delayed to get the needle out.The patient's treatment was not altered in anyway due to the prolonged surgery time there were no adverse patient consequences.No additional information was provided.

• Brand Name: MCRYL+ UD 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9244403
• Report Number: 2210968-2019-89107
• Device Sequence Number: 14055744
• Product Code: GAM
• UDI-Device Identifier: 10705031046573
• UDI-Public: 10705031046573
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

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 Expiration Date: 02/28/2021
• Device Catalogue Number: MCP494G
• Device Lot Number: PCK542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/28/2019
• Patient Sequence Number: 1