MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 HEX STRAIGHT ROD 5.5 X 180MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482807180
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the surgeon inserted the rod by the rod inserter.And the blocker tightened.The surgeon tried to remove the rod inserter.But, hex part of the rod was broken.Therefore the surgeon removed the broken piece.The surgery was completed.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The returned device was inspected and confirmed to be fractured in two pieces.Conclusion: the plausible root cause of this event is excess cantilever force applied during the rod insertion.
Event or Problem Description
It was reported that during surgery, the surgeon inserted the rod by the rod inserter.And the blocker tightened.The surgeon tried to remove the rod inserter.But, hex part of the rod was broken.Therefore the surgeon removed the broken piece.The surgery was completed.

• Brand Name: ES2 HEX STRAIGHT ROD 5.5 X 180MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6148652
• Report Number: 0009617544-2016-00486
• Device Sequence Number: 876648
• Product Code: NKB
• UDI-Device Identifier: 07613327001785
• UDI-Public: (01)07613327001785
• Combination Product (Y/N): N
• 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): 05/24/2017

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: 482807180
• Device Lot Number: S85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR