MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; DRIVER, AO CONNECTION, POLYAXIAL LOCKING SCREW

Model Number	Driver, AO Connection, Polyaxial Locking Screw
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system instructions for use warnings state: for safe effective use of the implant, the surgeon must be thoroughly familiar with the surgical technique for the device, implant, and associated instruments.As per our surgery usage charge form related with this case, requirement for the instrument listed in the surgical technique labeled as "single use only" was not met.Evidence suggests that the instrument has been used multiple times.Reusing instruments labeled "single use only" may compromise the structural integrity of the instrument.
Event or Problem Description
User submitted a report to the fda stating: during placement of a locking screw, the tip of a screwdriver broke flush into the head of x1 locking screw.Attempts were made to remove the broken screwdriver tip from the head of the locking screw.This could not be achieved as the tip was incarcerated within the head of the locking screw.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: DRIVER, AO CONNECTION, POLYAXIAL LOCKING SCREW
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; miami, fl
• MDR Report Key: 10282935
• Report Number: 3006742481-2020-00005
• Device Sequence Number: 667044
• Product Code: HWC
• UDI-Device Identifier: 00841506101286
• UDI-Public: 00841506101286
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/09/2020

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: Driver, AO Connection, Polyaxial Locking Screw
• Device Catalogue Number: DRVR-AOS-PLS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2020
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other