MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 50 MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48233550
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/23/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during the dvr procedure, tubes were used without clam shells.Standard blocker insert was used instead of torque wrench.After procedure was completed it was noticed in xray the 2 tulip heads had popped off from the screw post.Screws were replaced no further issues.Update: per additional correspondence with sales rep, the cavity was open and there was no need to reopen the patient at the time the reported event was noticed.
Additional Manufacturer Narrative
Visual analysis, device history review, complaint history review, risk assesment; the devices were inspected and it was confirmed that both tulip heads were disengaged from their main screw bodies.Further inspection showed deformity on the tulip head locking clips and on the tops of the main screw bodies.One screw was returned with the blocker still inserted into the tulip head.No relevant manufacturing issues were identified as all units met stryker specifications.It was determined that the surgeon was using a blocker inserter for final tightening.The surgical technique states that a torque wrench is to be used for final tightening as not to exceed 12nm.There is no way to determine the force exerted on the screw when using a blocker inserter for final tightening.Overtorqueing can lead to tulip disengagement.The most likely root cause is overtorqueing of the screw head due to using a blocker inserter for final tightening, which is a deviation from the surgical technique.
Event or Problem Description
It was reported that; during the dvr procedure, tubes were used without clam shells.Standard blocker inster was used instead of torque wrench.After procedure was completed it was noticed in xray the 2 tulip heads had popped off from the screw post.Screws were replaced no further issues.Update: per additional correspondence with sales rep, the cavity was open and there was no need to reopen the patient at the time the reported event was noticed.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 50 MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5808596
• Report Number: 0009617544-2016-00296
• Device Sequence Number: 1281621
• Product Code: KWP
• UDI-Device Identifier: 07613327001051
• UDI-Public: (01)07613327001051
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 06/23/2016

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: 48233550
• Device Lot Number: 105916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1