MAUDE Adverse Event Report: ARTHREX, INC. HTO IMPL,IBAL LG 10°/X-LG 9°; PLATE, FIXATION, BONE

Model Number	HTO IMPL,IBAL LG 10°/X-LG 9°
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2018
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.Device disposition is unknown.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was discovered during monthly maude review that the following incident was reported to the fda (mw5084048): during a procedure on (b)(6) 2018 the screw head (ar-13400l-10, lot 10129530) broke off in the tibia during the procedure.It was left in place for stability.Diagnosis was an acl tear/lateral meniscus tear.No further information was provided on the maude report.The above event description was entered by arthrex as shown on the maude database.This event description may contain claims or language from the reporter/complainant regarding arthrex device performance.Such claims have not been evaluated by any arthrex product experts.Arthrex¿s inclusion of any claims should not be construed as arthrex expressing agreement with such claims.The maude database did not contain facility/reporter information and therefore at this time no follow up can be performed.If additional information is received at a later date, this complaint will be evaluated as all complaints are in accordance with arthrex complaint handling procedures.

• Brand Name: HTO IMPL,IBAL LG 10°/X-LG 9°
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8455883
• Report Number: 1220246-2019-00985
• Device Sequence Number: 10870166
• Product Code: HRS
• UDI-Device Identifier: 00888867011731
• UDI-Public: 00888867011731
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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: 03/31/2022
• Device Model Number: HTO IMPL,IBAL LG 10°/X-LG 9°
• Device Catalogue Number: AR-13400L-10
• Device Lot Number: 10129530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other