MAUDE Adverse Event Report: OSTEOMED, LLC QUICK CONNECT RECIPROCATING SAW; HANDPIECE, ROTARY BONE CUTTING

Model Number	450-0241
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was opened as a result of the diagnosis findings during sro review.The device had been returned under sro number (b)(4) for service and repair.The diagnosis by the service and repair team was determined to be " when running at 75% speed as recommended, the saw blade will be loosened and finally ejected from the handpiece".Repair on the device will be completed per the sro work order.Additionally, the device will be tested to ensure all specifications are met, prior to return to the customer.Review of the device history records for the reported device revealed no anomalies.A review of the complaint database for part number 450-0241 revealed only one (1) complaint for blade not retained during use, which is the event in this report.The device is a reusable instrument; therefore, it is unknown how many times the device was used prior to this reported complaint event nor under what circumstances it was used.Based on the information received and the investigation performed, the root cause could not be determined.
Event or Problem Description
During review of the service and repair order (sro) log, it was noted the device evacuation/diagnosis stated "when running at 75% speed as recommended, the saw blade will be loosened and finally ejected from the handpiece".Follow up was conducted by the customer who reported this issue occurred during a surgery.Additional information provided indicated the saw blade kept loosening from the handpiece but would still "get the job done" although they had to keep pushing the blade in the handpiece.The surgery was not prolonged, and there were no adverse patient consequences.

• Brand Name: QUICK CONNECT RECIPROCATING SAW
• Common Device Name: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 19918756
• Report Number: 2027754-2024-00041
• Device Sequence Number: 8104125
• Product Code: KMW
• UDI-Device Identifier: 00845694037167
• UDI-Public: (01)00845694037167(30)1(11)230915
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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 Model Number: 450-0241
• Device Catalogue Number: 450-0241
• Device Lot Number: 1179693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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