MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 HEX RAD ROD 5.5 X 70MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	482806070
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; hex end broken off from a 5.5mm rad rod 70mm.Doc had to reposition the rod, so when he went to re-engage with the rod inserter, i noticed the hex end was still inside the rod inserter.Was able to get the rod out with a long kelly, and we used another same size rod with no incident.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; according to the material analysis, the rod was found to have fractured in a ductile bending overload due to an applied normal stress.The elemental composition was consistent with what is specified on the print.No material or manufacturing defects were found.The plausible root cause of this event is excess cantilever force applied during the rod insertion.
Event or Problem Description
It was reported that; hex end broken off from a 5.5mm rad rod 70mm.Doc had to reposition the rod, so when he went to re-engage with the rod inserter, i noticed the hex end was still inside the rod inserter.Was able to get the rod out with a long kelly, and we used another same size rod with no incident.

• Brand Name: ES2 HEX RAD ROD 5.5 X 70MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5821007
• Report Number: 0009617544-2016-00299
• Device Sequence Number: 481962
• Product Code: KWP
• UDI-Device Identifier: 07613327001679
• UDI-Public: (01)07613327001679
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• 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,Followup
• Report Date (Section B): 06/28/2016

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: 482806070
• Device Lot Number: M65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2016
• Supplement Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1