MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	07/27/2020
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 a patient had undergone an shoulder procedure (b)(6) 2019.Due to upper arm/ biceps tendon pain and discomfort the original surgeon performed a revision rtsa procedure (b)(6) 2020 at the same facility.During the revision procedure while attempting to remove the cup screw from the original procedure the driver tip twisted and the screw stripped.Sales rep states nothing out of the ordinary was noticed/ mentioned by the surgeon during the procedure.The revision was completed without any complications.The following devices were explanted during the revision and exchanged for larger sizes: ar-9564-2436-lat (lot 18.01992), ar-9501-07p (lot 18.02015), ar-9502f-36rcpc (lot 170111405), ar-9503s-06 (lot 19.00773), ar-9502rsc (lot 18.01082).The explanted devices are not available to return for evaluation.

• Brand Name: UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10414380
• Report Number: 1220246-2020-02041
• Device Sequence Number: 16815003
• Product Code: HSD
• UDI-Device Identifier: 00888867234215
• UDI-Public: 00888867234215
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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: 12/31/2022
• Device Model Number: UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)
• Device Catalogue Number: AR-9502F-36RCPC
• Device Lot Number: 170111405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other