MAUDE Adverse Event Report: ARTHREX, INC. UNI REVERS HUMERAL RESECTION SLIDE BLOCK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number UNI REVERS HUMERAL RESECTION SLIDE BLOCK

Device Problems Difficult to Advance (2920); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during a reverse total shoulder arthroplasty in the left shoulder, the cutting block with boom was unable to advance towards the patient's shoulder.The surgeon performed a free handed humeral head cut and went on with the case as usual.It was also reported that upon further inspection of the device, there is a very small screw near the entrance for the boom that is protruding into the area that contacts the boom.

• Brand Name: UNI REVERS HUMERAL RESECTION SLIDE BLOCK
• 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: 8569804
• MDR Text Key: 143728161
• Report Number: 1220246-2019-01071
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867266001
• UDI-Public: 00888867266001
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNI REVERS HUMERAL RESECTION SLIDE BLOCK
• Device Catalogue Number: AR-9507RGDP-1
• Device Lot Number: 051647
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other