MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS M A SCREW INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	486619095
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; there was some debris found inside a screwdriver shaft.The scrub nurse further reported that this looked like biological material.
Additional Manufacturer Narrative
Lot# 093213.Method: visual inspection; device history review; complaint history review; risk assessment.Results: inspection of the returned device did not reveal any identifiable debris or rust.No relevant issues were identified during manufacturing record review.Conclusion: a definite root cause could not be determined.
Event or Problem Description
It was reported that; there was some debris found inside a screwdriver shaft.The scrub nurse further reported that this looked like biological material.

• Brand Name: RADIUS M A SCREW INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6583946
• Report Number: 0009617544-2017-00215
• Device Sequence Number: 13640550
• Product Code: LXH
• UDI-Device Identifier: 07613327276091
• UDI-Public: (01)07613327276091
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2017

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: 486619095
• Device Catalogue Number: 486619095
• Device Lot Number: 093213
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1