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

Catalog Number	48511905
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during extraction surgery of, the tip of the extractor inner shaft broke.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: 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 almost 6 years.Conclusion: therefore, the probable root cause of this reported event is normal wear of instruments.
Event or Problem Description
It was reported that; during extraction surgery of, the tip of the extractor inner shaft broke.

• 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: 5769457
• Report Number: 0009617544-2016-00269
• Device Sequence Number: 16205818
• Product Code: LXH
• UDI-Device Identifier: 07613327270952
• UDI-Public: (01)07613327270952
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2016

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: 48511905
• Device Lot Number: 10F269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2016
• Supplement Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1