MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES BL OFFSET CUP IMPACTOR UNIVERSAL; 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	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cori assisted tha surgery, after impacting the cup and removing the bl offset cup impactor universal, the latch on the flat surface fell off along with the screw and spring.Tech was unable to put it back together.This occurred after the cup had been placed and wasn¿t needed anymore.There were no pieces that ended up in the patient as a result of this break.Surgery was resumed without any delay.No injuries to the patient were reported.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the bl offset cup impactor universal, part number 52856b, lot number 0623520061, used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.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 escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.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 not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with wear and tear of the impactor.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.
Additional Manufacturer Narrative
H3, h6: the bl offset cup impactor universal, part number 52856b, lot number 0623520061, used for surgery, was returned for evaluation.The reported problem was visually confirmed.The connection plate and its respective hardware is missing.A functional evaluation was not performed, as the complaint has been visually confirmed.Although the reported problem was confirmed, there are multiple causes and the most likely cause of this event cannot be determined without additional evidence.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.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.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: 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: 19258203
• Report Number: 3010266064-2024-00104
• Device Sequence Number: 16786491
• Product Code: OLO
• UDI-Device Identifier: 00885556909393
• UDI-Public: 885556909393
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083483
• 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,Followup
• Report Date (Section B): 10/30/2024

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
• Device Catalogue Number: 52856B
• Device Lot Number: 0623520061
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 10/23/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/01/2024; 10/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REAL INTELLIGENCE CORI / ROB10024.
• Patient Sex: Unknown