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

Catalog Number	SXPP1B413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	01/01/2018
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.What was the date of the initial procedure? what tissue layer was the suture used? what were the patient symptoms that caused the surgeon to remove the suture? what was the date the patient returned for suture removal? was a surgical procedure involved in removing the suture, or was the excess suture cut off? was the wound re-sutured? will the suture involved in the event be returning for evaluation? what is the surgeon opinion regarding the relationship of the spitting and the stratafix spiral? what is the current condition of the patient?.
Event or Problem Description
It was reported that a patient underwent a scoliosis procedure on an unknown date and barbed suture was used.The patient experienced suture spitting on an unknown date.The surgeon removed the suture to resolve the issue.The current patient status is unknown.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• 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: 8102578
• Report Number: 2210968-2018-77329
• Device Sequence Number: 1345937
• Product Code: NEW
• UDI-Device Identifier: 10705031236165
• UDI-Public: 10705031236165
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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 Expiration Date: 08/31/2019
• Device Catalogue Number: SXPP1B413
• Device Lot Number: LKP512
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/04/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention