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

Model Number 450-0241

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 283844573
• Report Number: 2027754-2022-00006
• Device Sequence Number: 1
• Product Code: KMW
• UDI-Device Identifier: 00845694037167
• UDI-Public: (01)00845694037167(30)1(11)181121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1