MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8701H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record review was performed for the finished device batch mkh106, 8701w and no non-conformances were identified.Attempts are being 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 the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the needle detached from the suture.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Investigation summary = > it was reported that the device had performance pull off suture needle.It was received for analysis two empty opened overwrap of product code 8701, lot mkh106.No needle or suture was returned for evaluation to determine the assignable cause of the performance breakage suture; therefore, the reported failure could not be evaluated.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.It could not be determined what may have caused the reported incident of: ¿during an unknown procedure the needle detached from the suture¿.

• Brand Name: PROLENE SUTURE 18"(45CM) 7-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8575591
• Report Number: 2210968-2019-80974
• Device Sequence Number: 284880
• Product Code: GAW
• UDI-Device Identifier: 10705031019294
• UDI-Public: 10705031019294
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 04/05/2019

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: 08/31/2023
• Device Catalogue Number: 8701H
• Device Lot Number: MKH106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/26/2019
• Patient Sequence Number: 1