MAUDE Adverse Event Report: ARTHREX, INC. 5.5X20MM PERIPHERAL SCREW, LOCKING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	AR-9563-20
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
Date of Event	09/21/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, it was reported by a patient via email that she underwent a reverse shoulder replacement on (b)(6) 2021, and is now experiencing sudden pain to her right shoulder when raising her arm overhead.X-rays suggest a stress fatigue fracture through the inferior screw.This demonstrates loosening of the left glenoshpere/baseplate.No additional information provided.Additional information requested.Additional information provided on 01/22/2021: implanted devices are as follows: right reverse tsr, arthrex univers 6mm stem with 36/+2 right suture cup, small 33/+3 humeral insert, 24mm monoblock base plate with 3 locking screws, +4/33mm glenophere.A ct scan of the right shoulder obtained at (b)(6) hospital is available for review.This demonstrates appropriate positioning of reverse tsr components.A minimal amount of fluid is seen.There is degenerative change a.C.Joint.No lucency around the implants.Due to the artifact the screw fracture is not visible.At this time a revision surgery will not take place.Additional information requested.
Additional Manufacturer Narrative
This supplemental is being done to change from serious injury to no harm as a revision surgery did not take place based on additional event update from the customer.
Additional Manufacturer Narrative
This supplemental submission is being done because a revision surgery took place on (b)(6) 2022 based on additional event update from the customer.This follow-up is to also add a device part number from the previously unknown part and lot number.
Event or Problem Description
On 08/04/2022, it was reported by a patient via email that she underwent a reverse shoulder replacement on (b)(6) 2021, and is now experiencing sudden pain to her right shoulder when raising her arm overhead.X-rays suggest a stress fatigue fracture through the inferior screw.This demonstrates loosening of the left glenoshpere/baseplate.No additional information provided.Additional information requested.Additional information provided on 01/22/2021: implanted devices are as follows: right reverse tsr, arthrex univers 6mm stem with 36/+2 right suture cup, small 33/+3 humeral insert, 24mm mono-block base plate with 3 locking screws,+4/33mm glenophere.A ct scan of the right shoulder obtained at lehigh valley hospital is available for review.This demonstrates appropriate positioning of reverse tsr components.A minimal amount of fluid is seen.There is degenerative change to the ac joint.No lucency around the implants.Due to the artifact the screw fracture is not visible.At this time a revision surgery will not take place.Additional information requested.Additional information provided 09/21/2022: implanted devices are as follows: ar-9560-24p, batch 8164; ar-9502f-36rcpc, batch: 19.04738; ar-9564-2433-lat, batch: 19.00839; ar-9503-3633-3, batch: 19.02941; ar-9563-20, batch: 2019004605; ar-9563-32, batch: 2019004423; ar-9562-32nl, batch: 2019002834; ar-9501-06p, batch: 19.04248.It was reported by the patient that the revision took place on (b)(6) 2022.

• Brand Name: 5.5X20MM PERIPHERAL SCREW, LOCKING
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 15249306
• Report Number: 1220246-2022-05393
• Device Sequence Number: 17681807
• Product Code: PHX
• UDI-Device Identifier: 00888867296824
• UDI-Public: 00888867296824
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• 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,Followup
• Report Date (Section B): 10/10/2022
• 2 Devices were Involved in the Event: 1 2

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: AR-9563-20
• Device Catalogue Number: 5.5X20MM PERIPHERAL SCREW, LOC
• Device Lot Number: 2019004605
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/04/2022; 08/04/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/21/2022; 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown