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

Model Number	450-0241
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed late because of an oversight during the investigation of this complaint in 2021 and subsequent recent review of complaints due to new management and postmarket personnel determined this complaint is mdr reportable.An investigation was not performed as the device has not been returned and device information is not available.
Event or Problem Description
During a procedure, the saw broke just below the black part of the saw.No patient harm was reported.

• 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: elhum wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 13242771
• Report Number: 2027754-2022-00006
• Device Sequence Number: 4585069
• Product Code: KMW
• UDI-Device Identifier: 00845694037167
• UDI-Public: (01)00845694037167(30)1(11)181121
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K971692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 01/12/2022
• 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