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

Catalog Number	52856B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a real intelligence cori assisted tha surgery, the locking mechanism of a cup impactor - offset broke and will not lock on the implant.The procedure was resumed, without any delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the cup impactor - offset, part number 52856b, serial number (b)(6), intended for treatment was returned for evaluation.The reported problem was confirmed with a visual inspection.The complaint hip impactor's middle locking mechanism is broken off and missing from the impactor.A functional evaluation was not performed as there is damage hindering inspection/evaluation.A complaint history review was performed by part number and similar complaints were identified.A review by lot/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.Although the reported problem was confirmed through a visual inspection, a definitive cause could not be determined.Factors contributing to the reported problem may have been associated to product mishandling.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: 23586292
• Report Number: 3010266064-2025-00251
• Device Sequence Number: 21215435
• Product Code: OLO
• UDI-Device Identifier: 00885556909393
• UDI-Public: 885556909393
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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): 12/31/2025

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: 52856B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/31/2025
• 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