MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES INSTRUMENT ADAPTER STARLOCK V2012; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	55085
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (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 inherent device and/or procedural risks 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 conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a cori-assisted tka, the instrument adapter starlock v2012 that go on the cup handle were bent.After case, it was checked again and the array was able to be seen if pointed the arrays towards the ceiling meaning that the array bent.Surgeon did not use cup navigation and returned to use the leg length and offset.Surgery was performed, changing to manual instrumentation.It is unknown if there was any delay.No patient complications were reported.
Additional Manufacturer Narrative
H3, h6: the instrument adapter starlock v2012, part number 55085, lot number unknown, intended 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.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.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 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.D2a, d2b.

• Brand Name: INSTRUMENT ADAPTER STARLOCK V2012
• 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: 20150807
• Report Number: 3010266064-2024-00186
• Device Sequence Number: 4248969
• Product Code: OLO
• UDI-Device Identifier: 00885556909348
• UDI-Public: 885556909348
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/02/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 55085
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/02/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown