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

Catalog Number	48511820B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of screwdriver shaft broke off into the screwdriver/screw interface.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed upon visual inspection.Manufacturing files were reviewed and no anomalies were found.Manufacturing review revealed an instrument over 9 years old.Conclusion: the probable root cause is normal wear based on instrument age.
Event or Problem Description
It was reported that the tip of screwdriver shaft broke off into the screwdriver/screw interface.

• Brand Name: REFLEX HYBRID QUICK TURN INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8011427
• Report Number: 0009617544-2018-00248
• Device Sequence Number: 13795213
• Product Code: LXH
• UDI-Device Identifier: 07613327277012
• UDI-Public: 07613327277012
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 48511820B
• Device Lot Number: 088066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1