MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48511906B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been discarded.
Event or Problem Description
It was reported that the tip of a reflex hybrid revision driver draw rod screw extractor broke off intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that the tip of a reflex hybrid revision driver draw rod screw extractor broke off intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per additional correspondence, the tip fractured while final tightening.The device was not used at a difficult angle, the patient's bone quality was reported to be hard, and "a little bit" force was applied on the device.The device has been used 10 times in 2 months.Reflex hybrid surgical technique instructs users to not utilize the revision driver as an insertion driver.It is likely that the tip fractured while using the device for final tightening screw.Other potential causes include: hard bone quality of patient, application of excess force and normal wear of device.

• Brand Name: REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR
• 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: 13079127
• Report Number: 0009617544-2021-00241
• Device Sequence Number: 4152578
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: 07613327276855
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/01/2022

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: 48511906B
• Device Catalogue Number: 48511906B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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