MAUDE Adverse Event Report: ARTHREX, INC. INTBRACE LGMNT REPR AUGMNT KIT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	INTBRACE LGMNT REPR AUGMNT KIT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
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 in mailed in medwatch that the following incident (mw5096382) had been reported to the fda: "patient was undergoing a scheduled right ankle ligamentous reconstruction with arthrex anchors and internal brace, ar-1678-cp.Intra-op, the implant broke while being inserted.An 0.8mm piece remains on the implant, approximately, 0.8mm piece inserted into the bone by the surgeon.The surgeon and the arthrex equipment are aware and are in agreement that the implant is sufficient as is.Discussed with the surgeon who reported that the length of the implant was sufficient for anchoring.No patient harm.Patient discharged to home same day as planned." the medwatch report does not contain facility or reporter information.Therefore no follow is possible at this time.

• Brand Name: INTBRACE LGMNT REPR AUGMNT KIT
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10698188
• Report Number: 1220246-2020-02234
• Device Sequence Number: 14217541
• Product Code: MAI
• UDI-Device Identifier: 00888867020887
• UDI-Public: 00888867020887
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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 Expiration Date: 10/31/2021
• Device Model Number: INTBRACE LGMNT REPR AUGMNT KIT
• Device Catalogue Number: AR-1678-CP
• Device Lot Number: 10441259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/19/2020
• 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