MAUDE Adverse Event Report: STRYKER SPINE-LEESBURG SCREW DRIVER W/ THREAD; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	8801-90034
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an ozark screwdriver had no thread to load screw onto driver intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.
Additional Manufacturer Narrative
A visual inspection was performed and revealed the following.Inspection confirmed the device to have fractured at the threaded inner tip.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history record review was performed for this lot and two similar complaints were identified.The ozark guide and surgical technique was reviewed and the surgical technique indicates that the driver must be used with a 12 in-lbs torque limiting handle.If the instrument is subjected to a force greater than 12 in-lbs., then it may result in device damage.Correspondence with the sales representative indicates that a torque limiting handle was used.It is possible that the instrument was torqued past the indicated 12 in-lb mark; however, from the available information, a cause cannot be established conclusively.
Event or Problem Description
It was reported that an ozark screwdriver had no thread to load screw onto driver intra-operatively.No adverse consequences, surgical delay or medical intervention were reported. the procedure was completed successfully.

• Brand Name: SCREW DRIVER W/ THREAD; SIZE 10
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-LEESBURG; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12313509
• Report Number: 3004774118-2021-00251
• Device Sequence Number: 11865139
• Product Code: LXH
• UDI-Device Identifier: 10888857400863
• UDI-Public: 10888857400863
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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 Catalogue Number: 8801-90034
• Device Lot Number: JKKY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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
• Patient Sex: Female