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

Catalog Number	EPH8720H
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 via: the initial event indicates there was an issue with a 6/0 suture.However, 2 product codes in each pc were provided of 8706h (size 6/0) and eph8720 (size 5/0) is only 1 suture involved in this event for each patient/pc? was there an issue with both product codes 8706h (with possible lot numbers rlbccq/ sjbkla) and eph8720 for each patient event/pc? or was there an issue with only 1 suture, but it is unknown if the suture was product code was 8706h or eph8720? over the course of 4 weeks there was an issue with both 8706h (with possible lot numbers rlbccq/ sjbkla) and eph8720.The hospital is not able to state during which cases which suture was exactly problematic but both had been raised to me as complaints.Please clarify the issue with the suture: is the exact suture issue known (suture breakage vs.The suture pulling out of the needle)? the exact problem is that the thread snaps, since they are using 5-0, 6-0 and they are non magnetic as soon as that happens it is becoming very difficult to find the needle.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Possible lot: rlbccq/ sjbkla events reported via: 2210968-2023-08459.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle disappeared from the end of a double ended 6/0 - we needed to x-ray and excluded it from the wound but never found it.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE HS BLU 36IN 5-0 D/A C-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18057182
• Report Number: 2210968-2023-08458
• Device Sequence Number: 6962223
• Product Code: GAW
• UDI-Device Identifier: 10705031233447
• UDI-Public: 10705031233447
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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 Catalogue Number: EPH8720H
• Device Lot Number: SPBHMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown