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	01/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; trying to remove previously implanted plate from patient, when the inner fixation rod broke while being utilized with removal driver.There was a delay while they extracted broken tip from screw head, but ultimately did not impact the patient and used a secondary inner rood to finish removal.Case was finished successfully, and the instrument has been used hundreds of times.Update 1/16/2017: the plate was being to removed to correct an adjacent level degeneration that required a new plate due to the previous fusion already fused.Not a revision surgery.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed and no issues were found for this lot number.The driver screw extractor was confirmed visually to have a fractured tip.Conclusion: the instrument was used about 100 times, so the probable root cause is normal wear.
Event or Problem Description
It was reported that; trying to remove previously implanted plate from patient, when the inner fixation rod broke while being utilized with removal driver.There was a delay while they extracted broken tip from screw head, but ultimately did not impact the patient and used a secondary inner rood to finish removal.Case was finished successfully, and the instrument has been used hundreds of times.Update 1/16/2017: the plate was being to removed to correct an adjacent level degeneration that required a new plate due to the previous fusion already fused.Not a revision surgery.

• 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: 6301347
• Report Number: 0009617544-2017-00044
• Device Sequence Number: 36489
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: (01)07613327276855
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/18/2017

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: 140648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1