MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	48232601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that vitallium rod broke during pre-op preparation (bending of the rod).
Additional Manufacturer Narrative
Method: visual analysis, device history review, complaint history review, risk assesment.Result: the returned rod was confirmed to have fractured at the laser marking dot.The laser marking dot was inspected using a microscope and voids were identified.These voids can act as stress risers when placed on the tensile side of the bend, which they were in this case.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the customer reported event is the presence of voids on the lasermarking dot.
Event or Problem Description
It was reported that vitallium rod broke during pre-op preparation (bending of the rod).

• Brand Name: XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5610935
• Report Number: 3005525032-2016-00047
• Device Sequence Number: 542777
• Product Code: KWP
• UDI-Device Identifier: 04546540608642
• UDI-Public: (01)04546540608642
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• 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): 04/04/2016

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: 48232601
• Device Lot Number: LDT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2016
• Supplement Report FDA Received Date: 08/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1