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

Catalog Number	48511906B
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the tip of the draw rod broke off in the screw head and was unable to remove from screw.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: no manufacturing issues were discovered and the device was found to be in the field for 6 years conclusion: the probable root cause is normal wear due to the instrument age.
Event or Problem Description
It was reported that; the tip of the draw rod broke off in the screw head and was unable to remove from screw.

• Brand Name: REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6399550
• Report Number: 0009617544-2017-00083
• Device Sequence Number: 780119
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: (01)07613327276855
• Combination Product (Y/N): N
• 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): 05/18/2017

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: No Information
• Device Catalogue Number: 48511906B
• Device Lot Number: 109528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1