MAUDE Adverse Event Report: OSTEOMED, LLC 1.6MM X4MM AUTODRIVE SCREW

Model Number	211-1604
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on going and a supplemental report will be submitted on completion of investigation.
Event or Problem Description
During the craniotomy procedure, the screw broke while screwing in and a tiny piece was left in the patient and not removed.There were no adverse consequences to the patient.The device is not returning as it was lost by the facility.
Additional Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned or evaluation.Therefore, a root cause could not be determined.A review of the device history record confirmed there were no nonconformances associated with the lot and associated bulk lot, and all inspections passed.A two year review of complaints and distribution number of the part 211-16xx family of screws revealed a complaint rate with low probablity of occurrence.Risk documentation was reviewed and indicated the hazard and associated harms are captured in risk documentation.Additionally, review of labeling indicated the warning section states that excessive torque during insertion of screws may lead to failure of the implant/screw.

• Brand Name: 1.6MM X4MM AUTODRIVE SCREW
• Common Device Name: 1.6MM X4MM AUTODRIVE SCREW
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho road; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: flor rivera ; 3885 arapaho rd.; addison, TX 75001 ; 9726774600
• MDR Report Key: 13003260
• Report Number: 2027754-2021-00024
• Device Sequence Number: 4883735
• Product Code: HWC
• UDI-Device Identifier: 00845694002363
• UDI-Public: (01)00845694002363(10)1158394301(11)210524
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K974785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 211-1604
• Device Catalogue Number: 211-1604
• Device Lot Number: 1158394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian