MAUDE Adverse Event Report: SEASPINE INC. MALIBU SPINAL SYSTEM; POLYAXIAL SCREW DRIVER SHAFT

Model Number	91-2111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remaining shaft of the instrument has not been provided for evaluation.Additionally, no radiographs have been provided for analysis.While the reported complaint cannot be confirmed or properly evaluated at this time, given the age of the device (approximately 10 years), the failure reported is consistent with normal age and wear.Review of labeling: warnings and precautions: seaspine instruments should only be used with seaspine implants.Do not attempt to use with other competitive devices.Avoid application of excessive stress on surgical instrumentation.Carefully read and follow any package insert which accompanies the implants to be used with this instrumentation.Instruments must be cleaned and decontaminated before they are returned to the manufacturer for any reason.Carefully inspect all instruments prior to use.Do not use an instrument that is severely marred or worn, or a cutting instrument with dull edges.Note that at some time, instruments may wear out and should be replaced.
Event or Problem Description
On (b)(6) 2020, the patient underwent spinal surgery consisting of seaspine's malibu pedicle screw system.Seaspine was informed on 30 oct 2020 that the implant screwdriver broke while implanting a screw.The driver tip was left in the screw in-situ.No injury was reported, nor any additional medical or surgical treatment.

• Brand Name: MALIBU SPINAL SYSTEM
• Common Device Name: POLYAXIAL SCREW DRIVER SHAFT
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 10909207
• Report Number: 3012120772-2020-00092
• Device Sequence Number: 2706284
• Product Code: NKB
• UDI-Device Identifier: 10889981080587
• UDI-Public: 10889981080587
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K122571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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: 91-2111
• Device Catalogue Number: 91-2111
• Device Lot Number: MW06706B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1