MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, MEDIUM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS VAULTLOCK GLENOID, MEDIUM
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/27/2020
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.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 an apex surgery with the vaultlock the device protruded.It was stated that the surgeon measured the pegs of the vault lock and the drill bit.The surgeon measured 20 mm of the drill bit and 16mm of the central peg.It was also reported that the cement impactor was too long.The surgeon had to fill the holes with a bone graft which lead to a prolonged surgery.Update 05-nov-2020: further information about the procedure were provided.The surgeon was reaming the glenoid by hand using the nautilus reamer and there was no aggressive reaming incorporated.When drilling the superior peg the surgeon perforated the bi-cortical bone.He fixed the situation by using bone chips from the resected humeral head.It was further reported that the surgeon has not used the cement pressurizer ar-9235 according to the surgical technique but the puncher ar-9233 instead since he believes that the pressurizer has to long pegs.The surgery was extended by 10-15 minutes to fill the caused holes.

• Brand Name: UNIVERS VAULTLOCK GLENOID, MEDIUM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10843380
• Report Number: 1220246-2020-02341
• Device Sequence Number: 3629421
• Product Code: KWS
• UDI-Device Identifier: 00888867239326
• UDI-Public: 00888867239326
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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: 10/31/2024
• Device Model Number: UNIVERS VAULTLOCK GLENOID, MEDIUM
• Device Catalogue Number: AR-9106-02
• Device Lot Number: 1027261920
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other