MAUDE Adverse Event Report: EVOLUTION SPINE LLC WHISTLER MODULAR PEDICLE SCREW SYSTEM

Model Number	WI-003
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon was performing the final tightening of an inserted pedicle screw/tulip when the tip of the driver broke free of the driver.The surgeon left the broken-off tip in the head of the pedicle screw and inserted the rod as per normal procedure which secured the broken-off tip in the pedicle screw head, preventing it from migrating.
Additional Manufacturer Narrative
The cause of the malfunction of this instrument could be due to several possibilities, including: the surgeon unintentionally induced excessive torque on the instrument beyond intended use causing it to exceed its intended design strength and yielding as a shearing fracture of the tip.The hardness of the bone was higher than normal requiring the surgeon to apply torque beyond its intended design strength and yielding as a shearing fracture of the tip.The preparation of the bone for screw insertion was improper requiring the surgeon to intentionally apply torque beyond its intended design strength and yielding as a shearing fracture of the tip.The instrument was unintentionally not fully inserted into the screw head, resulting in the torque not being applied to the full length of the tip causing it to exceed its intended design strength and yielding as a shearing fracture of the tip.A review of the dhr paperwork, including material certs, revealed nothing out of the ordinary.There were no manufacturing issues with wi-003, lot: 4168.The results of the investigation indicate that the cause of the failure was torque beyond the yield strength of the instrument.Because it is not known whether the patient had hard bone, or if the surgeon properly seated the driver into the screw the actual root cause of the broken driver tip cannot be determined.

• Brand Name: WHISTLER MODULAR PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): EVOLUTION SPINE LLC; 2300 n haskell ave; dallas TX 75402
• Manufacturer (Section G): EVOLUTION SPINE LLC; 2300 n haskell ave; dallas TX 75402
• Manufacturer Contact: todd wallenstein ; 2300 n haskell ave; dallas, TX 75402
• MDR Report Key: 15709174
• Report Number: 3012428435-2022-00021
• Device Sequence Number: 17386654
• Product Code: NKB
• UDI-Device Identifier: 00195860004685
• UDI-Public: 00195860004685
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: WI-003
• Device Catalogue Number: WI-003
• Device Lot Number: 4168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WC-C, 00195860000014, LOCKING CAP CANNULATED; WC6540-N, 00195860002636, SCREW DIA 6.5 X 40MM; WT55-R, 00195860004654, REDUCTION TULIP, QTY 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic