MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 36IN 5-0 D/A C-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPH8720H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
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.Additional information was requested and the following was obtained: did the suture break or needle pulled off? there were cases when the thread flew out of the needle and also came off at a level closer to the needle.How many devices failed in this procedure? the exact number wasn't tracked, but not less than 6 episodes.Did the device issue occur before use on patient or during actual suturing? one issue occured upon opening and loading the needle, other issues occurred during the sewing of anastamoses.Event/procedure date - key account manager (b)(6) received a complaint only (b)(6) 2020 during her visit to this clinic.However there had been similar issues before this day, but dates of issues hadn't been fixed by clinic (clinic hadn't informed (b)(6) about that).Lot number - mph532.How was case completed? - unavailable information.Any adverse patient consequences and what medical/surgical intervention was performed to manage them? none of the patients were injured, after the incident the anastamoses were sutured by other threads.Are samples being returned for evaluation? - the clinic saves the remaining box with 14 blisters for examination.It will be sent for the expertise in near future.Note: events for this patient reported in: 2210968-2020-02193, 2210968-2020-02194, 2210968-2020-02195, and 2210968-2020-02196.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts were being made to obtain the following information.If 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 an unknown date and suture was used.During the procedure, the suture pulled off the needle when sewing the anastomosis.Another like device was used.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 05/05/2020.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances 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.

• Brand Name: PRLNE HS BLU 36IN 5-0 D/A C-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9848177
• Report Number: 2210968-2020-02197
• Device Sequence Number: 2929483
• Product Code: GAW
• UDI-Device Identifier: 10705031233447
• UDI-Public: 10705031233447
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: EPH8720H
• Device Catalogue Number: EPH8720H
• Device Lot Number: MPH532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 05/05/2020
• Patient Sequence Number: 1