MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. 2.8MM GLENOID DRILL SHAFT; BIT, DRILL

Catalog Number	DRS-0926-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a reverse total shoulder, using the peripheral baseplate reamer, the doctor noticed something off with the driver while spinning, pulled it out of the joint and the spring and collar inside the 2.8mm glenoid drill shaft fell out on the floor.The attachment was still in the t-handle and caught the outer black shaft.Nothing fell inside the patient; it was confirmed with x-rays.The procedure was resumed, without any delay, with a change in surgical technique, by using a ronjour.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H11: h2: additional information on: d4 (lot number).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H11: the associated device was returned and evaluated.The visual inspection revealed that the device is completely disassembled with the retainer ring not returned with the rest of the device.The entire device is worn from use.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.

• Brand Name: 2.8MM GLENOID DRILL SHAFT
• Common Device Name: BIT, DRILL
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23900408
• Report Number: 3002788818-2025-00141
• Device Sequence Number: 5128516
• Product Code: HTW
• UDI-Device Identifier: 00885556860236
• UDI-Public: 885556860236
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2026

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: DRS-0926-001
• Device Lot Number: QJ2053
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 01/20/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/08/2026; 01/23/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown