MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	FIBERTAPE
Health Effect - Clinical Code	Reaction (2414)
Date of Event	03/31/2020
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 arthrex device ar-7237 was used.The tape was inserted across the metacarpals to stabilize the metacarpal arch.After 6 months of insertion the patient had allergic reactions.No further information received at the moment.

• Brand Name: FIBERTAPE
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9985554
• Report Number: 1220246-2020-01806
• Device Sequence Number: 3676631
• Product Code: GAT
• UDI-Device Identifier: 00888867041738
• UDI-Public: 00888867041738
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: FIBERTAPE
• Device Catalogue Number: AR-7237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other