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

Catalog Number	8634G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? what instruments were used to grasp the needle? where was the needle grasped during use? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? was an xray performed to confirm if the needle is retained in the patient¿s tissue? in what structure/tissue was the needle retained? if retained, is the entire needle retained in the patient¿s eyelid? has surgery been scheduled to remove the needle? if surgery has been performed, please provide date of second procedure.When the needle is removed, will it be returned for evaluation? what is the patient current status?.
Event or Problem Description
It was reported that a patient underwent an ectropion repair procedure on (b)(6) 2019 and suture was used.During the right lower eye lid procedure, the surgeon went for the pass and when they went to grab for the needle the suture was present but the needle was not.It is unknown how the suture separated from the needle.The needle was not retrieved.Post op, after waiting for the patients swelling to go down they are attempting to obtain the needle from the patients eye lid.The current status of the patient is unknown.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).The following additional information was received: the patient demographic info: age, gender, weight, bmi at the time of index procedure 76 yo male, bmi33.5; hx htn, diabetes, hyperlipidemia, sleep apnea.The diagnosis and indication for the index surgical procedure? unk.What instruments were used to grasp the needle? unk.Where was the needle grasped during use? unk.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? unk.Was an xray performed to confirm if the needle is retained in the patient¿s tissue? yes.Post op xray taken next day in what structure/tissue was the needle retained? orbit of the eye lid if retained, is the entire needle retained in the patient¿s eyelid? yes, due to severe swelling, surgeon opined it was safe to leave the needle, then to risk further surgery to remove.The needle did not break, but pulled off at the suture attachment area.Has surgery been scheduled to remove the needle? not at present.If surgery has been performed, please provide date of second procedure.Na.When the needle is removed, will it be returned for evaluation? na.What is the patient current status? pt had severe swelling and bruising during the procedure.The surgeon opined that the swelling was a reaction to the local anesthetic used.The patient did not stop taking anticoagulants (baby asa and fish oil) until day of procedure.Was recommended to stop 1 week prior.The patient was examined (b)(6) 2019 and the swelling has reduced.The needle is still retained in eyelid orbit.The surgeon will not remove the needle due to risks with repeat procedure.The patient condition is listed as stable.

• Brand Name: PRLNE BLU 18IN 4-0 S/A PC-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8897776
• Report Number: 2210968-2019-85627
• Device Sequence Number: 419774
• Product Code: GAW
• UDI-Device Identifier: 10705031018167
• UDI-Public: 10705031018167
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 8634G
• Device Lot Number: MAB793
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/16/2019; 09/04/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 08/23/2019; 09/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR