MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL PDS+; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.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.Date of the procedure? on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how many times was the patient operated in the same area? what date did the patient present with symptoms? was there any deficiency with the suture? if yes, what was the deficiency? lot number? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.
Event or Problem Description
It was reported that the patient underwent a spine procedure on an unknown date and barbed suture was used.Following the procedure, the suture began to ¿spit¿ and eventually patient was brought in for re-op and wash-out about six to eight-week post op.The patient's current condition is unknown.Additional information has been requested.

• Brand Name: STRATAFIX SPIRAL PDS+
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8130249
• Report Number: 2210968-2018-77501
• Device Sequence Number: 1770260
• Product Code: NEW
• UDI-Device Identifier: 10705031235878
• UDI-Public: 10705031235878
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

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: SXPP1B414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/04/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention