MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI UNI SCREW 6MM X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179788640

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

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 that dr.(b)(6) was performing a posterior spinal fusion today.Upon final tightening of the set screw, it was revealed that set screw would not properly tighten.Dr.(b)(6) tried a few different things to see if it would torque, it would not.He then removed the rod from the screw, removed the screw in question and placed a new screw.Once the new screw was in, the construct was final tightening to proper specifications.The uniplaner screw that came out was damaged significantly.Patient consequence? no.Action taken for procedure: removed damaged uniplaner screw and replaced it with a new uniplaner screw.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.The expedium ti uniplanar 6x40mm uniaxial screw (product code: 1797-88-640, lot number: rl271111) was returned to the complaint handling unit for evaluation.It was observed at the start of analysis that the screw had its saddle forced up and into the tulip head.The tulip head features little damage, but the screw head¿s drive feature does show some signs of stress/stripping.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 saddle being forced out of place may have occurred due to unexpectedly high amounts of force placed on it during the procedure.The evidence of stripping to the drive feature may be evidence of that force.A related driver may have not been inserted fully flush with the drive feature of the screw, resulting in high amounts of force being placed across a small area at the top of the drive feature.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: EXP TI UNI SCREW 6MM X 40MM
• 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: 8268707
• MDR Text Key: 135163752
• Report Number: 1526439-2019-51266
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034081397
• UDI-Public: (01)10705034081397
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179788640
• Device Catalogue Number: 179788640
• Device Lot Number: RL271111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 12 YR