MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8934H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Eye Injury (1845); No Code Available (3191)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Surgical dissection.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.What is the size of the needle piece retained in the eye socket? is the needle piece more than half the length of the needle? were x-rays taken to confirm the location of the needle piece? does the surgeon plan to remove the needle piece in the future? what is the surgeon opinion of consequence to the patient due to retained needle piece? can you identify the lot number of the product prolene 8934h? what is the current condition of the patient?.
Event or Problem Description
It was reported that a patient underwent eye surgery on (b)(6) 2018 and suture was used.The needle broke off from suture during procedure.The surgeon attempted to remove the needle piece but was unsuccessful.The needle piece is retained in the eye socket.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4) 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.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.Additional information was requested and the following was obtained: did any piece(s) of the needle fall into the patient¿s tissue? yes 2.Was the needle piece(s) retrieved? no 3.What measures were taken to retrieve the broken piece? instrumentation were used to try and retrieve piece of needle that broke off.4.Was there any additional tissue damage as a result of searching for the needle piece? no 5.Were x-rays taken to locate the needle piece(s)? patient had a post op ct scan 6.At what location was the needle found? lateral orbit ¿ stuck in bone 7.Was the patient brought back to or to have needle removed or was the needle removed during the initial procedure? no patient does not have a medical aid and will have to pay for the procedure out of his own pocket.8.Does a piece of the needle remain in the patient¿s tissue? if yes, what tissue structure is it located? yes.Later orbit 9.If retained, what is the surgeon's opinion of consequences to the patient? at moment nothing, but if in future it is dislodged and perforates the eye - blindness can occur.10.What in the physicians opinion are the factors contributing to the event? not sure, never experienced this situation before.11.What is the lot number of the device used? as per product complaint logged.

• Brand Name: PROLENE SUTURE 36"(90CM) 5-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7221943
• Report Number: 2210968-2018-70470
• Device Sequence Number: 16606192
• Product Code: GAW
• UDI-Device Identifier: 10705031022058
• UDI-Public: 10705031022058
• Combination Product (Y/N): N
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8934H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention