MAUDE Adverse Event Report: STRYKER SPINE-US SPECIALTY SELF RETAINING HYBRID SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IS2081HYB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection, the tip of the reflex specialty self retaining hybrid screwdriver was missing.There was no procedure associated with this event.No adverse consequences occurred.
Additional Manufacturer Narrative
A visual inspection performed found the tip of the screwdriver to be fractured and the device is no longer functional.Among fractured tip, wear and tear was identified on the device.It was reported that the screwdriver had been used for a number of years.Per device history review the device is in the field for over 13 years.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no similar complaints were identified.It was initially reported that upon inspection of a screwdriver in a warehouse, the tip fractured off and it was missing.There was no patient involvement.The surgical technique guide was reviewed: ¿the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery¿ the cause of the reported event is normal wear due to device age.Factors such as consistent use of the instrument throughout its lifetime, cleaning and sterilization may have caused fatigue fracture.
Event or Problem Description
It was reported that during inspection, the tip of the reflex specialty self retaining hybrid screwdriver was missing.There was no procedure associated with this event.No adverse consequences occurred.

• Brand Name: SPECIALTY SELF RETAINING HYBRID SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12801023
• Report Number: 3004024955-2021-00025
• Device Sequence Number: 14770040
• Product Code: LXH
• UDI-Device Identifier: 07613327278828
• UDI-Public: 07613327278828
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: IS2081HYB
• Device Catalogue Number: IS2081HYB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2008
• 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: Unknown