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

Model Number	UNI REVERS HUMERAL RESECTION SLIDE BLOCK
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2019
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 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 or Problem 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
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8569804
• Report Number: 1220246-2019-01071
• Device Sequence Number: 1537832
• Product Code: LXH
• UDI-Device Identifier: 00888867266001
• UDI-Public: 00888867266001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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 Model Number: UNI REVERS HUMERAL RESECTION SLIDE BLOCK
• Device Catalogue Number: AR-9507RGDP-1
• Device Lot Number: 051647
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other