MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8699G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: was more than half the needle retained in the patient? -yes.Are any plans in place to remove the needle piece in the future? - no.Was there any additional tissue damage as a result of searching for the needle piece? - no.Were there any patient consequences? - no.Could you please provide the lot number?- no.Procedure name? - laceration closure on scalp.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent a laceration closure procedure on (b)(6) 2021 and the suture was used on scalp.During the procedure, the needle broke and lodged in scalp.X-ray was done.More than half the needle retained in scalp.Surgeon decided not to remove it.There were no patient consequences reported.There are no any plans to remove the needle piece.
Additional Manufacturer Narrative
Date sent to the fda: 06/03/2021.Additional information was requested, and the following was obtained: procedure- scalp repair.The needle broke just after the tip.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.

• Brand Name: PRLNE BLU 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11934773
• Report Number: 2210968-2021-05241
• Device Sequence Number: 3165910
• Product Code: GAW
• UDI-Device Identifier: 10705031019263
• UDI-Public: 10705031019263
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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 Model Number: 8699G
• Device Catalogue Number: 8699G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1