MAUDE Adverse Event Report: DEPUY SYNTHES SPINE PEDICLE SCREW NO CUT +5; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 22232840

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Two (2) vsp bone screws no cut [product code: 2223-2840, lot numbers: m1d98 and m1r65],] were returned to the complaint handling unit (chu) for evaluation.Analysis of the screws¿ cut surfaces revealed that there were burrs, which are raised / extra material, present of the surfaces of these screws.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.A root cause for the threads of the locking caps peeling from the nut cannot be positively determined.It was observed that there were burrs present on the cut surfaces of the bone screws.The burring was most likely caused when the screws were cut during the initial surgery.The screws are placed in the spine and the tapered nuts along with the locking nuts are placed over the screws.The screws are then cut to shorten the overall length.When the surgeon went to remove the screws from the patient postoperatively, the burrs could have potentially nicked and sheared off the threads of the locking nuts.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6), 2015, the removal surgery of vsp implanted at other facility (l5-s1) was performed.During the final irrigation of the surgical site, a metal fragment was found.The irrigation was done in the surgical site and the procedure was completed without delay.The surgeon suspected that it was a metal fragment from the implants caused by abrasion at the removal.He strongly requested the investigation and the return of the metal piece and implants.Complaint is a reportable malfunction.Decision tree is reassessed and complaint determined to be reportable based on evaluation of returned product.Device was returned for examination.During device investigation on 10-01-2015, investigator noted burrs on the device.There was no report of any adverse consequences to a patient or surgical delay.However, intra-operative breakage of hardware/torn threads has been known to result in a delay of more than thirty minutes and/or a portion of the broken hardware/torn threads remaining in a patient.

• Brand Name: PEDICLE SCREW NO CUT +5
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5128239
• MDR Text Key: 27495001
• Report Number: 1526439-2015-10833
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK980485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 22232840
• Device Lot Number: M1R65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1