MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 7X45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186731745

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported during a one level mis lumbar fusion, a 7x45mm viper cortical fixed screw head popped off of the shaft during insertion.At the beginning of the case, doctor stated how hard and psoriatic the patients bone was, making it difficult to insert the jamshidi into the pedicle.He bent 2 jamshidis and 2 pedicle probes in the process of placing the k-wires in the pedicle.Upon insertion of the screw, he had difficulty advancing the screw.(b)(6) ((b)(6) employee) noticed the viper extension on the screw wasn't turning and told the doctor.At this time, the doctor stopped trying to advance the screw and tried to remove it instead.This is when the screw head popped off of the shaft of the screw.The doctor tried to remove the screw shaft with a straight expedium screwdriver, which also broke in the process.He then used an ¿easy out¿ to back out the shaft of the screw.No part of the screw was retained in the patient.Patient consequence? : no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual examination revealed that the head of the device had been separated from its shank.Signs of operative use were noted as evidenced by superficial markings, with damage to the drive feature of the screw head.Exerting a significant amount of force on the tulip head and saddle, potentially at a significant angle, may be sufficient to dislodge the saddle.It was noted that the threads on the shank of the screw were stripped indicating that force was applied to remove the screw shaft.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the 5.5 ti cortical fix 7 x 45 mm falling apart cannot be determined from the sample and the information provided.A potential root cause may be excessive force inadvertently placed on the drive feature of the screw during tightening, potentially at a significant angle, resulting in the saddle falling apart during use.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 were found, 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: 5.5 TI CORT FIX 7X45MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8033619
• MDR Text Key: 127886292
• Report Number: 1526439-2018-51041
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034352015
• UDI-Public: (01)10705034352015
• Combination Product (y/n): N
• PMA/PMN Number: K110216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186731745
• Device Catalogue Number: 186731745
• Device Lot Number: 212446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1