MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 6.0 X 50MM POLYAXIAL SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 179710650

Device Problem Torn Material (3024)

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

Event Date 05/13/2015

Event Type  malfunction  

Event Description

During the fixation of lumbar fusion procedure, the surgeon noted that the thread of screw fell off.Changed the new screws to complete the procedure.There was no report on patient injury.

Manufacturer Narrative

A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Three (3) mmsi polyaxial screws [product codes: 1797-10-650 (x2) and 1797-10-645, lot numbers: ardcdh (x2) and arcd2h] were returned to the complaints handling unit (chu) for evaluation.Device underwent visual inspection.Visual inspection has confirmed the reported complaint.The first two thread rows, on both sides of the tulip head, for each device were torn 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.The root cause for the final tightener becoming stripped cannot be positively determined.One probable root cause may likely be that the tightener was not fully seated inside the setscrew when torsional force was applied.This may have resulted in the distal tip becoming stripped.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.

• Brand Name: 6.0 X 50MM POLYAXIAL SCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767 CH-
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 4824085
• MDR Text Key: 5903973
• Report Number: 1526439-2015-10525
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 179710650
• Device Lot Number: ARDCDH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1