MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS UNKNOWN DRILL; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Model Number UNKNOWN

Device Problem Device Remains Activated (1525)

Patient Problem Damage to Ligament(s) (1952)

Event Date 10/25/2020

Event Type  Injury  

Manufacturer Narrative

No conclusion can be drawn.No evaluation was performed, as the perforator bit was discarded and the motor was not returned.If the motor is returned in the future, product analysis may be performed.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.We will continue to track and trend this complaint type.Pma / 510(k) #: no information available on device to confirm applicable 510(k).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a craniotomy while drilling bur holes, it appears when the perforator bit reached the appropriate depth in the bone, the clutch mechanism did not stop and caused the motor to spin in the surgeon's hand.On follow-up, it was reported that an injury/sprain on the surgeon's wrist was experienced and that a specialist may be seen if the pain persists.On further follow-up, it was reported that the motor will not be returned and the perforator bit was discarded.No information was available on the model or serial number of the motor drill or perforator bit used.

• Brand Name: UNKNOWN DRILL
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: tricha miles ; 4620 north beach street; ft. worth, TX 76137-3291 ; 7635140379
• MDR Report Key: 10907385
• MDR Text Key: 218650076
• Report Number: 1625507-2020-00222
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other