MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); No Code Available (3191)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that suturetape was used during a procedure on a patient.The patient began to experience a rejection of the suturetape and thus, had it removed.Additional information provided 11/21/2019: the original procedure was performed on (b)(6) 2019.It was a revision of acromial and rcr procedure.The patient was experiencing wound draining and itching in her feet.The suturetape was removed on (b)(6) 2019.Additional information provided 11/27/2019: the patient underwent the revision due to non-union.The date of the original procedure is unknown.Since the removal, the patient has taken a variety of sutures to her allergist to test.The surgeon believes her genetics are the issue-not the suturetape.

• Brand Name: SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9443710
• Report Number: 1220246-2019-01467
• Device Sequence Number: 2219672
• Product Code: GAT
• UDI-Device Identifier: 00888867229228
• UDI-Public: 00888867229228
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE
• Device Catalogue Number: AR-7500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/10/2019
• 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: Other