MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 4.5MM CENTER SCREW 40MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	SCW-0990-507-40
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an aetos reverse total shoulder, the head of the 4.5mm center screw 40mm broke while trying to advance the screw, leaving it too proud to engage the glenosphere set screw.Dr.Miller made the decision to remove the 15 deg augment baseplate full wedge and in the process of removing it, the threads of the baseplate inserter broke off in the center post of the baseplate.The thread inside the baseplate that guides and captures the center screw also broke from inside the post, leaving the center screw (without the screw head) with the capture thread still inside the vault of the glenoid.Dr.Miller engaged the inserter onto the baseplate and tried backslapping the inserter handle and wiggling the handle/baseplate to disengage the baseplate from the native glenoid.After also using an osteotome to try to lever the baseplate off the glenoid, he was stuck with the baseplate may a few millimeters off the glenoid.Thinking the center screw was holding him up, he tried to spin the baseplate counterclockwise to try to unscrew the baseplate off the center screw.After going back and forth for a long time, the screw threads of the machined, baseplate & glenosphere inserter broke off flush with the face of the baseplate.The procedure was resumed, after a significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H6: medical device problem code.Section h6: the associated device was returned and evaluated.The visual inspection revealed that the screw head had sheared off.The screw threads near the screw head were deformed/damaged.The screw itself was slightly bent and the fractured screw head was not included in the return.The damage to the screw threads could be a result of the attempted removal of the screw once the screw head fractured off.Similarly, the bend in the screw could also be a result of the screw removal after the breakage occurred.The most likely root cause for the screw head shearing off is excessive torque applied during insertion.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 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.According to the implant and instrumentation manufacturing specification, all implants and instrumentation will be 100% visually inspected for any defect or damage.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should 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 40MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 18614114
• Report Number: 3002788818-2024-00012
• Device Sequence Number: 7444889
• Product Code: KWS
• UDI-Device Identifier: 00885556813607
• UDI-Public: 885556813607
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K220847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SCW-0990-507-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown