MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C SCREWDRIVER - STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The returned screwdriver was confirmed to have its tip fractured upon visual inspection.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.The plausible root cause for the tip fracture is applying ductile overload on the instrument due to excessive pivoting or angulation during insertion and normal wear and tear of the device.
Event or Problem Description
It was reported that during a cervical fusion procedure, a piece of the screwdriver broke off.It was noticed when putting the instrument back in the set, that a little piece (1mm by 1mm) was missing.The missing piece was not found on the operating table or in the set.Therefore rx examinations were done to find out if the piece was still present in the patient (see attached in intake tab).

• Brand Name: ANCHOR C SCREWDRIVER - STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6327501
• Report Number: 0009617544-2017-00058
• Device Sequence Number: 1610782
• Product Code: LXH
• UDI-Device Identifier: 07613327267082
• UDI-Public: (01)07613327267082(11)130222(10)12C170
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 02/13/2017

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: 48328500
• Device Lot Number: 12C170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR