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); Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receiving the fda report (mw5089046), a call was made to the representative to get more information form the complaint.The information provided was that the surgeon was having issues with the variable angle driver tip during final torqueing.We were unable to get more information regarding this event via the representative.The instrument was not returned to be investigated.The information provided is insufficient to conclude a causation of what actually happened.Testing was performed on a similar driver model in stock and was seen to be within spec of the allotted torque limits.
Event or Problem Description
User submitted a report to the fda stating: while plating a variable angle screw, the tip of the driver cold welded in the head of the screw and broke off.Decision was made to leave the tip of the driver in the screw head, as screw had good placement and tip was cold welded without possibility of migration.

• 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: 10299817
• Report Number: 3006742481-2019-00002
• Device Sequence Number: 10935143
• Product Code: HWC
• UDI-Device Identifier: 00841506101286
• UDI-Public: (01)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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 09/11/2019
• Initial Report FDA Received Date: 07/20/2020
• 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