MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXP TI UNI SCREW 7MM X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179788745

Device Problem Material Separation (1562)

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

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One (1) expedium 5.5 top loading uni-planar 7x45mm polyaxial screw [product code: 1797-88-745] was returned to the complaints handling unit (chu) for evaluation.Visual examination revealed that the polyaxial screw¿s inner cap (saddle) had become twisted approximately 90 degrees from its intended location.Additionally, the polyaxial screw featured some light signs of wear inside the drive feature.A notch is also visible on the inner edge of the saddle.While these marks are not significant enough to damage the polyaxial screw at large, they may be indicative of the forces placed on it during insertion and tightening.The swaging operation appears to have been performed due to visible deformations on the inside of the tulip head component.Based on these observations, it is believed that unexpectedly high amount of forces was placed on the inner saddle and the polyaxial screw¿s drive feature during tightening, resulting in the saddle being forced out from its intended location.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 definitive root cause for the polyaxial screw¿s saddle becoming forced out from its intended location cannot be positively determined.However, based on the device observations, it is believed that unexpectedly high amount of forces was placed on the inner saddle and the polyaxial screw¿s drive feature during tightening, resulting in the saddle being forced out from its intended location.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

During insertion the screwhead was twisted 90 degrees.

• Brand Name: EXP TI UNI SCREW 7MM X 45MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6180845
• MDR Text Key: 62684072
• Report Number: 1526439-2016-10930
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K142460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 179788745
• Device Lot Number: TBKZU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2015
• 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