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	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, it was reported by a facility representative via email that an ar-2923ps peek pushlock and an ar-7500 suturetape was implanted successfully into patient during an arthroscopy right shoulder with capsulorrhaphy.After the procedure the patient complaint of pain and tightness and since the procedure, patient was not progressing with physical therapy.Patient was referred for a second opinion and had another arthroscopy procedure.During the procedure, surgeon discovered the tissue surrounding the anchors to be red and inflamed.The anchors were removed along with the surrounding irritated tissues.Patient has a known allergy to neoprene.
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.If the device becomes available for evaluation, a follow-up report will be submitted.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13569549
• Report Number: 1220246-2022-04486
• Device Sequence Number: 3769763
• Product Code: GAT
• UDI-Device Identifier: 00888867229228
• UDI-Public: 00888867229228
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown