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

Model Number	450-0240
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/01/2020
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 2020 and subsequent recent review of complaints due to new management and postmarket personnel determined this complaint is mdr reportable.The following is the investigation performed at the time of this complaint in 2020: this device was returned for evaluation on 11 february 2020.The evaluation determined the device would stall during use due to damaged bearings.Review of complaint history from 2017-2020 did not reveal any overheating complaints.Review of capa and ncr history revealed no capas or ncrs related to this issue.Review of risk documentation was performed and indicated this issue is captured.The instructions for use for this product states "if the device becomes objectionably warm during normal operation, discontinue use of the device.".
Event or Problem Description
On (b)(6) 2020, personnel from dr.Guyette's office called osteomed sr.Product manager asking about suggested maintenance schedule for the reciprocating saw.The caller asked if the reciprocating saw required lubrication similar to that of the drill and reported the saw was used seldomly, and most likely had never been lubricated, to the best of her knowledge.The caller stated the surgeon had used the saw recently, and noted the saw had gotten hot during use, resulting in an "insignificant" burn to the patient burned during the procedure.It was recommended to the caller to no longer use the saw and return to osteomed for evaluation, service, and/or repair.Informaiton obtained during follow up regarding the burn was that the degree of burn was "insignificant".No further informaiton could be obtained.

• Brand Name: 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: 13242270
• Report Number: 2027754-2022-00003
• Device Sequence Number: 4569282
• Product Code: KMW
• UDI-Device Identifier: 00845694037167
• UDI-Public: 00845694037167
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 450-0240
• Device Catalogue Number: 450-0241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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