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

Model Number	48511905
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the inner shaft of the extraction screwdriver broke during a case.I was not in case as it was just a removal.
Additional Manufacturer Narrative
The device was inspected and it was confirmed the tip of the extractor fractured off.No relevant manufacturing issues were found upon device history review.Therefore, the probable root cause of this reported event is overtightening.
Event or Problem Description
It was reported that; the inner shaft of the extraction screwdriver broke during a case.I was not in case as it was just a removal.

• Brand Name: REFLEX-HYBRID 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: 6694615
• Report Number: 0009617544-2017-00277
• Device Sequence Number: 1243972
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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 Model Number: 48511905
• Device Catalogue Number: 48511905
• Device Lot Number: 105515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR