MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,LAT ANKLE RECON; SCREW, FIXATION, BONE

Model Number	IMPL SYS,LAT ANKLE RECON
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
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
It was reported during a lateral ankle allograph reconstruction the fiber wire was cut during insertion.Another fiber wire was used and was torn and broke again.A third time was attempted and the same event occurred.The surgeon laid the tendon into the hole and pushed it in with the screw.The case was completed with no further issues.The patient is fine to date.

• Brand Name: IMPL SYS,LAT ANKLE RECON
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12332936
• Report Number: 1220246-2021-03513
• Device Sequence Number: 14127210
• Product Code: HWC
• UDI-Device Identifier: 00888867020771
• UDI-Public: 00888867020771
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• 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): 08/17/2021

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: 10/31/2024
• Device Model Number: IMPL SYS,LAT ANKLE RECON
• Device Catalogue Number: AR-1675BC-CP
• Device Lot Number: 12208689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/17/2021
• 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