MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 4.5MM CENTER SCREW 30MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	SCW-0990-507-30
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).Section b5 describes the malfunction of 2 devices: 4.5mm center screw 25mm / pn: scw-0990-507-25: covered in (b)(4).4.5mm center screw 30mm / pn: scw-0990-507-30: covered in (b)(4).
Event or Problem Description
It was reported that, during a reverse shoulder arthroplasty surgery, a 4.5mm center screw 25mm was initially used but failed to achieve compression of the far cortex.The 25mm screw was then backed out, the bone was redrilled and a 4.5mm center screw 30mm was selected.The screw spun, but did not receive purchase of the far cortex of the glenoid vault resulting in loss of compression.The 30 mm screw was left in the construct and the procedure was completed after a non-significant delay.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.However, based on the information provided, the unsatisfactory experience could be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, definitive contributing clinical factors cannot be concluded.However, based on the correspondence that the bone was redrilled and the 30mm center screw ¿spun and didn¿t compress¿, a user technique/procedural variance cannot be ruled out as the surgical technique notes to avoid over reaming (reduces depth of glenoid vault) and that there is ¿no need to drill¿ the glenoid guide wire has sufficiently prepared the bone to receive the screw and to insert using the t-15 star driver screws should not be tightened using a power driver¿.The current patient status is unknown.The patient impact included the reported lack of bony purchase/loss of compression of both central screws (initial 25mm and 30mm backup); however, the 30mm center screw reportedly remained in the construct to complete the procedure within a non-significant delay.It is unknown if sufficient compression was achieved during compression peripheral screw placement.Further patient impact cannot be determined, although a post-surgical recovery phase would be anticipated.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for aetos shoulder system revealed in precautions that knowledge of surgical techniques, proper reduction, selection and placement of implants, are essential to successful outcomes.Besides, each surgeon must evaluate the appropriateness of the procedure and instruments used during the procedure.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 4.5MM CENTER SCREW 30MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18887372
• Report Number: 3002788818-2024-00032
• Device Sequence Number: 20717818
• Product Code: HSD
• UDI-Device Identifier: 00885556813584
• UDI-Public: 885556813584
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K220847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SCW-0990-507-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GBP-0990-500-2 / GLENOID BASEPLATE CENTERED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown