MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CUP IMPACTOR - OFFSET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	52856B
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	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tha, while the patient was under anesthesia, the bottom plate of a cup impactor - offset popped off, letting the springs and pegs come out as well.All pieces retained and not missing.The procedure was resumed, without any delay, using the same device.No further complications were reported.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H3, h6: 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
The cup impactor - offset, part number 52856b, serial number (b)(6) , used for treatment was returned for evaluation.The reported problem was confirmed with a visual inspection.The complaint cup impactor has a disconnected connection plate that is in a separate sealed autoclave pouch along with the spring and pegs that connect it to the impactor.A complaint history review was performed by part number, and similar complaints were identified.A review by serial number was performed and no similar complaints were identified.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The most likely cause of this event is associated with wear and tear.Based on the investigation, no containment or corrective action is recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: CUP IMPACTOR - OFFSET
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24079278
• Report Number: 3010266064-2026-00008
• Device Sequence Number: 12232075
• Product Code: OLO
• UDI-Device Identifier: 00885556909393
• UDI-Public: 885556909393
• Combination Product (Y/N): N
• Initial Reporter Country: AF
• PMA/510(K) Number: K193307
• Number of Events Summarized: 1
• Summary Report (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): 02/23/2026

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
• Device Catalogue Number: 52856B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown