MAUDE Adverse Event Report: OSTEOMED, LLC 1.2MM PILOT DRILL, 8MM STOP, HEX SHANK EXT; SCREW, FIXATION, INTRAOSSEOUS

Model Number 111-1281

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/21/2022

Event Type  malfunction  

Event Description

It was reported during an endo brow lift procedure, the surgeon was drilling the first hole by hand to place a screw when the drill tip broke in the patient's bone.The fragment was unable to be retrieved and remains in the patient.It was reported there were no adverse consequences to the patient, and this issue resulted in a 10 minute procedural delay.A pneumatic drill was used to complete the procedure.

Manufacturer Narrative

The results of the investigation are inconclusive based on the information received.Should the device be returned for evaluation, a follow up report will be submitted.

Manufacturer Narrative

The device history record was reviewed and no anomalies were found.All inspections passed.The device was received for evaluation.The evaluation confirmed the drill tip was fractured at the beginning of the drill helix.The drill was examined to the inspection plan by quality control personnel.The dimensions that could be measured all met the drawing specifications.Current inventory was reviewed as part of the complaint investigation process.Thirty-eight (38) parts from this lot (lot 1156330) were quarantined.An inspection of the critical dimensions was developed with the quality control supervisor.This included the web thickness and diameter of the drill tip.A sample size corresponding to an aql of 1.0, thirteen (13) parts, were examined by quality control personnel.All inspections passed and the parts were returned to stock.A two year review of complaints determined this was the only complaint for the 111-12xx pilot drill family.Based on the information received and the investigation performed, the root cause of the reported event is unknown.

• Brand Name: 1.2MM PILOT DRILL, 8MM STOP, HEX SHANK EXT
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 15096954
• MDR Text Key: 301853458
• Report Number: 2027754-2022-00038
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00845694052412
• UDI-Public: (01)00845694052412(10)1156330(30)1(11)210315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 111-1281
• Device Catalogue Number: 111-1281
• Device Lot Number: 1156330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White