MAUDE Adverse Event Report: ETHICON INC. EB EXC 4GRN/4WHT 30IN 2-0 DA RB-1 8PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	PXX43
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested and the following was obtained: were fragments generated? unknown, if yes, were they removed easily without additional intervention? no, could you please explain if there was additional intervention required to retrieved the device? if yes please explain.No additional fragments were generated; just the needle popped off and landed in the patient¿s chest the needle was easily removed from the chest and no additional intervention was needed.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2020 and suture was used.During the procedure, the needle popped off at the swage and fell into the patient chest cavity.The needle was recovered from chest cavity.Procedure was successfully completed.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: EB EXC 4GRN/4WHT 30IN 2-0 DA RB-1 8PLGT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10963440
• Report Number: 2210968-2020-09685
• Device Sequence Number: 19887202
• Product Code: GAT
• UDI-Device Identifier: 10705031049314
• UDI-Public: 10705031049314
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2020

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: 02/28/2025
• Device Model Number: PXX43
• Device Catalogue Number: PXX43
• Device Lot Number: QCMACH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/07/2020
• Patient Sequence Number: 1