MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH

Device Problems Break (1069); Connection Problem (2900); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, it was reported by a sales representative via sems that while in a tka case the silver base on collared handle (ar-613-1) came off during keel punch removal, we attached the second handle to remove punch and continued with procedure, also during this procedure the poly impactor (ar-613-98) would not easily connect to the handle.The tech used a mallet to get it onto handle.All broken pieces were retrieved, and the was no patient effect reported.

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.

• Brand Name: IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12814113
• MDR Text Key: 286576788
• Report Number: 1220246-2021-03917
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867115941
• UDI-Public: 00888867115941
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH
• Device Catalogue Number: AR-613-1
• Device Lot Number: 051834
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Date Device Manufactured: 11/12/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1