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

Model Number	48511905
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was trying to back out and reposition a screw and the tip of the inner draw rod snapped off within the screw.All broken fragments were retrieved and there are no adverse health consequences to the patient.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence with the sales representative.The device was not returned for evaluation.No relevant manufacturing issues were found upon device history review.No adverse consequences to the patient was reported in the actual event.The general instrument ifu states that 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.Upon manufacturing history review, the age of the device was found to be 4 years.Per email correspondence with the sales rep, it was used every fortnight.Therefore, the probable root cause of this reported event is normal wear.
Event or Problem Description
It was reported that the surgeon was trying to back out and reposition a screw and the tip of the inner draw rod snapped off within the screw.All broken fragments were retrieved and there are no adverse health consequences to the patient.

• Brand Name: REFLEX-HYBRID SCREW EXTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7402137
• Report Number: 0009617544-2018-00076
• Device Sequence Number: 19065261
• Product Code: LXH
• UDI-Device Identifier: 07613327270952
• UDI-Public: (01)07613327270952
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 06/25/2018

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: 48511905
• Device Catalogue Number: 48511905
• Device Lot Number: 130938
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1