MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48511820B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that as the surgeon was attempting to back out a screw, the tip of a reflex hybrid screw extractor inner shaft fractured off inside the screw head.There were no adverse consequences to the patient.The screw was removed successfully with another device without reported surgical delay.
Event or Problem Description
It was reported that as the surgeon was attempting to back out a screw, the tip of a reflex hybrid screw extractor inner shaft fractured off inside the screw head.There were no adverse consequences to the patient.The screw was removed successfully with another device without reported surgical delay.
Additional Manufacturer Narrative
The device information in section d was updated to reflect the correct device information received.H3: has been updated as the status and location of the device is unknown.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that as the surgeon was attempting to back out a screw, the tip of a reflex hybrid screw extractor inner shaft fractured off inside the screw head.There were no adverse consequences to the patient.The screw was removed successfully with another device without reported surgical delay.
Additional Manufacturer Narrative
Visual inspection of the device confirmed that the tip fractured.The fractured piece was not returned.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The device is 4 years old and has been in this sales rep possession for approximately 2 years.Per additional information, the device was not used at a difficult angle, the surgeon did not use complex maneuvers or excessive forces on the device, bone quality of the patient is unknown.Per the surgical technique: surgical instruments are provided by stryker spine and must be used to assure accurate implantation of the device.While rare, intraoperative fracture or breakage of instruments can occur.Instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, disposal attention.Instruments must be examined for wear or damage prior to surgery and after sterilization.Based on the provided information, the likely root cause of the reported event is normal wear and tear due to device age.

• Brand Name: REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12451068
• Report Number: 0009617544-2021-00149
• Device Sequence Number: 17028345
• Product Code: LXH
• UDI-Device Identifier: 07613327277012
• UDI-Public: 07613327277012
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 12/20/2021

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 Model Number: 48511820B
• Device Catalogue Number: 48511905R
• Device Lot Number: 203228
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 10/14/2021; 11/24/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 11/10/2021; 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• 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