MAUDE Adverse Event Report: OSTEOMED, LLC UNKNOWN; DRILL

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once more information is obtained.

Event Description

On (b)(6) 2022, notification was received from the competent authority in the (b)(6) , that the facility had reported and incident to mhra that occurred on (b)(6) 2021.Per the incident report form provided by mhra, "during surgery bone was drilled to put in fixation-drill snapped".It was also reported there was no injury/adverse consequences to the patient, carer, or healthcare professional.Device informaiton was not provided (i.E.Model number, batch number, serial number), and no other informaiton is available.Follow up is being conducted to obtain additional information and determine if device is being returned for evaluation.

Manufacturer Narrative

Adverse incident report form with incident number (b)(4), was received from mrha on 13 january 2022.Per the form, it was reported "during surgery bone was drilled to put in fixation-drill snapped".Additionally, it was reported there were no adverse consequences to the patient, the drill was removed, and the patient was informed.Follow up was conducted on (b)(6) 2022, and response was received from the surgeon on (b)(6) 2022.Additional information received indicated the procedure being performed was fusion of the 1st metatarsal cuneiform joint.During the procedure, the surgeon was drilling across the 1st metatarsal and cuneiform joint to enable the surgeon to put in a screw.When the surgeon pulled the drill bit back out of the bone only half of it was attached and the other half remained in the cuneiform.The surgeon was able to remove the broken drill bit, but in order to do so, the surgeon had to drill around the drill bit to give sufficient access to remove it.As there was a large cavity in the cuneiform as a result of the drill bit removal, the surgeon had to put 2 plates across the joint to stabilize it rather than just 3 screws.Per the surgeon, the patient's foot is healing well.The surgeon reported the device is not being returned for evaluation.The surgeon did not have device information- that is, device model number, lot number, serial number, etc.Is unknown.The only information provided by the user is that the device was a 1.8mm drill bit.The investigation was completed on 7 february 2022.The results of the investigation were inconclusive since the device was not returned, and device information (part number, batch/lot number) was unknown.Aditional review of the device history record could not be performed.The part description provided by the initial reported was "1.8mm drill bit".Osteomed has 17 part numbers with a description that contains any of these words "1.8mm drill" or "1.8mm drill bit." these part numbers are 320-0012, 320-0018, 320-0312, 320-5018, 320-5018-sp-01, 320-5018-sp-02, 320-5018-sp-05, 320-5118, 320-5118-sp-01, 320-5118-sp-02, 320-5118-sp-05, 320-5218, 320-5218-sp-01, 320-5218-sp-02, 320-5218-sp-05, 320-6010, and 320-6012; since an exact part number was not reported, these part numbers were reviewed as part of this investigation.A 2-year complaint history review was performed using these part numbers, and there were two (2) complaints for broken drills for part number 320-6010; however, it is unknown if the device involved in this event was part number 320-6010.Furthermore, a review of labeling and risk documentation was performed which revealed both adequatly address the reported event.The root cause of the reported event could not be determined.

• Brand Name: UNKNOWN
• Type of Device: DRILL
• 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: 13268583
• MDR Text Key: 292609786
• Report Number: 2027754-2022-00008
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• 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: Unknown
• Patient Sequence Number: 1