MAUDE Adverse Event Report: ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via phone that an ar-8990 fibertak¿ dx suture anchor had an issue.During a lateral ankle reconstruction procedure, a brostrom repair on (b)(6) 2022, when the surgeon was trying to use the inserter to implant the anchor, the metal tip with the suture anchor broke off inside the patient, the metal tip was left inside the patient, and it was not confirmed if the anchor itself was left as well inside the patient.The surgeon did not retrieve the broken fragment, he was able to use another ar-8990 fibertak¿ dx suture anchor, a different lot number, to complete the surgery successfully with no further impact to the patient.On (b)(6) 2022, the same surgeon performed a revision surgery on the patient to remove the broken metal tip/piece from the patient, the surgery site itself from the previous surgery was left alone.This revision surgery was completed successfully, the metal tip was successfully removed and the patient is fine to date.

• Brand Name: DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: 15445707
• Report Number: 1220246-2022-05493
• Device Sequence Number: 18023049
• Product Code: MBI
• UDI-Device Identifier: 00888867265004
• UDI-Public: 00888867265004
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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: DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS
• Device Catalogue Number: AR-8990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/19/2022
• 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