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

Catalog Number	52856B
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: the bl offset cup impactor universal, part #52856b, sn #(b)(6) , used for surgery, was returned for evaluation.The exterior condition shows moderate wear.The release lever, and its internal components (spring, and a nut) were missing.The reported problem was visually confirmed.Functional evaluation was performed.The reported problem was confirmed.The offset cup impactor universal was disassembled.The release lever, and its internal components (spring, and a nut) were missing.The most likely cause that the bl offset cup impactor universal has been damaged during using, shipping, or processing.A review of the user manual confirmed steps to ensure not to use the product if it was damaged.A review of manufacturing records indicates the device met all specifications upon release into distribution.A complaint history review was performed by part number and similar complaints were identified.A review by lot/serial was performed and no similar complaints were identified.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
Event or Problem Description
It was reported that, during a real intelligence cori assisted tha surgery, while impacting, it was noticed that a silver plate came off.After further investigation, it was found that it came from one (1) bl offset cup impactor universal.It was the small plate that is underneath the impactor.A spring, and what appeared to be a nut, were also found to be detached from the impactor.No broken pieces fell into or were left in patient.The procedure was resumed without delay cautiously using the same device, and no injuries were reported as a result.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).

• Brand Name: BL OFFSET CUP IMPACTOR UNIVERSAL
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21307031
• Report Number: 3010266064-2025-00031
• Device Sequence Number: 12804165
• Product Code: OLO
• UDI-Device Identifier: 00885556909393
• UDI-Public: 885556909393
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083483
• 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): 03/17/2025

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: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REAL INTELLIGENCE CORI: (B)(6), (B)(6)
• Patient Sex: Unknown