MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 18IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP497G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2019
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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The needle became detached from the suture material during use.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/02/2019.H3 device evaluation summary: the actual device was received for evaluation.An empty opened foil, an empty labeled winding former and a detached needle of product code mcp497, lot # mmk703 were received for evaluation.During the visual inspection of a detached needle, the swage and attachment area were noted to be as expected.Body fluids was present on needle and marks by use of a surgical instrument could be observed at the edge of the barrel hole, this condition causes the needle pull off.The suture was not received for evaluation.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause of the performance pull off - suture needle is an improper handling.

• Brand Name: MCRYL+ UD 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8875855
• Report Number: 2210968-2019-85320
• Device Sequence Number: 16693484
• Product Code: GAM
• UDI-Device Identifier: 10705031046603
• UDI-Public: 10705031046603
• Combination Product (Y/N): N
• PMA/510(K) Number: K050845
• 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,Followup
• Report Date (Section B): 07/12/2019

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: 10/31/2020
• Device Catalogue Number: MCP497G
• Device Lot Number: MMK703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 09/18/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 08/14/2019; 10/02/2019
• Patient Sequence Number: 1