MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA BLOCKER; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	03756230
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
Event or Problem Description
It was reported that; one cap was broken when doctor try to use tightener to insert and lock the cap.
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 blocker was inspected and it was found that it had fractures.Conclusion: the plausible root cause of the event is use of force for tightening.
Event or Problem Description
It was reported that; one cap was broken when doctor try to use tightener to insert and lock the cap.

• Brand Name: XIA BLOCKER
• 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: 6482780
• Report Number: 3005525032-2017-00047
• Device Sequence Number: 1344694
• Product Code: KWP
• UDI-Device Identifier: 04546540147257
• UDI-Public: (01)04546540147257
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2017

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 Model Number: 03756230
• Device Catalogue Number: 03756230
• Device Lot Number: C5H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: 03/16/2017
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1