MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SKULL PIN 2000 PKG-5-STRL; COMPONENT, TRACTION, INVASIVE

Catalog Number AC020

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 12/24/2013

Event Type  malfunction  

Event Description

It was reported that a patient had been implanted with crown sliders and skull pin on (b)(6) 2013.A surgery to remove the devices was performed on (b)(6) 3013, after an anterior skill pin had backed out.During the removal, the skull pin anterior head could not be disassembled from the slider, and so the devices were removed.There were no adverse patient consequences as a result, and the physician intends to perform another halo system installation procedure on (b)(6) 2013.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.The incident in this report is associated with the device reported in mfr report # 1526439-2014-10546.

Manufacturer Narrative

Visual inspection noted that the two skull pins were still screwed into the 3d crown zero sliders.Various attempts to unscrew the skull pins were taken.However, it was very difficult to fully unscrew the skull pins.It appears that the skull pin threads have become ceased inside the sliders causing the skull pins not being able to unscrew.A review of the device history record (dhr) for the skull pin 2000 pkg-5-strl could not be conducted as the lot number etched on the skull pin does not match supplier ((b)(4)) records as it is an invalid lot number.Therefore, without the lot numbers, a review of the manufacturing records cannot be completed.A 12-month review of the complaint trend analysis for the skull pin 2000 pkg-5-strl was conducted on the specific product code from this complaint as the product family does not exist for this product.It was noted that there were no related complaints associated with the skull pin coming off and sliding; of which there was no harm to the patient but potential may exist if the fault were to recur.Review of complaints found no significant trends.The root cause cannot positively be determined.It is inconclusive of how the skull pin has loosened and slided off.No corrective action/preventive action is required as there has been no issue identified in the manufacturing or release of this device, and there have been no systematic trends.Therefore, this complaint will be closed with no further action required.

• Brand Name: SKULL PIN 2000 PKG-5-STRL
• Type of Device: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3575961
• MDR Text Key: 17160198
• Report Number: 1526439-2014-10544
• Device Sequence Number: 1
• Product Code: JEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK993099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AC020
• Device Lot Number: 16488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/24/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 01/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: 3D CROWN ZERO DEG SLIDER