MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA, TIBIA TRIALING SHIM 2/3MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IBAL UKA, TIBIA TRIALING SHIM 2/3MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
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 that the ar-611-7 trialing shim is damaged.Additional information received on 1/27/2021: the rep reported the device broke during the final insertion for cement hardening phase.The device broke on insertion into the knee.All broken fragments were fully retrieved and accounted for.No unplanned incisions were necessary.The case was completed by using valgus force to provide pressure.
Additional Manufacturer Narrative
It was reported that the device broke during insertion.The reported event is confirmed upon investigation of the returned product.Visual evaluation identified that the shim had fractured in half with notable damage around the fracture point.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion and subsequent removal after the cementing phase.

• Brand Name: IBAL UKA, TIBIA TRIALING SHIM 2/3MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11314109
• Report Number: 1220246-2021-02576
• Device Sequence Number: 4069222
• Product Code: LXH
• UDI-Device Identifier: 00888867240346
• UDI-Public: 00888867240346
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 02/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IBAL UKA, TIBIA TRIALING SHIM 2/3MM
• Device Catalogue Number: AR-611-7
• Device Lot Number: 051543
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other