MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 5-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8698G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a dental graft procedure on (b)(6) 2021 and suture was used.During the procedure, the operating staff had to open 4 packages as the suture line would break off rendering the driver too short.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained: could you please confirm if the 4 sutures broke? i have enclosed attached photographs of the broken sutures.When was the each suture broke (in the package, during removal from package, during handling or during use on the patient)? please specify the first photo was taken (b)(6) , 2021.It broke upon removal of the package.The second and third photos in this email are the other three broken sutures that occurred on (b)(6), 2021.They were broken while the doctor was using them.You can see from the last photo that all three broken sutures came from the same box/lot.Was there any adverse consequence associated with the patient? no to both individual instances.Have any of these events where the suture snapped prematurely been previously reported to ethicon? if yes, provide the respective reference number(s).No i have not previously reported tis problem before, however, it does some to happen quite frequently with the 6-0 prolenes.If not, please create a product complaint for each event and provide the respective reference number(s).N/a.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 related to: 2210968-2022-00986, 2210968-2022-00987, and 2210968-2022-00988.

• Brand Name: PRLNE BLU 18IN 5-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13510179
• Report Number: 2210968-2022-00989
• Device Sequence Number: 14549297
• Product Code: GAW
• UDI-Device Identifier: 10705031019232
• UDI-Public: 10705031019232
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 06/30/2022
• Device Model Number: 8698G
• Device Catalogue Number: 8698G
• Device Lot Number: LHR930
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/26/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 04/07/2022
• Date Device Manufactured: 07/18/2017
• 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