MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 4.35X40; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	199723440
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional procode: mni.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that during spinal fixation surgery on an unknown date, it was noted that after completing the total spinal construct with the expedium verse advanced system and tightening of the setscrews, the tabs were broken off under the topnotch instead of flush with the topnotch as described in the surgical technique.This caused the topnotch to also break off the screwhead.The construct was loosened, this specific screw was replaced with a new one, and the surgery was completed successfully.This report is for an expedium verse 5.5 screw 4.35 x 40.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
(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 inspection of the screw revealed that the breakage had occurred below the top notch interface.The other broken half was not returned.It was also noted that the threads of the tulip head were torn.Fracture analysis was subsequently performed on the screw.The fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the top-notch interface underwent a static failure.The absence of rotational deformation and a termination site implies that the top-notch interface was broken under a cantilever force.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.The root cause of the top notch interface breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a probable root cause is static overload failure due to a single, sudden, unexpectedly high force placed on the top-notch interface.With the information provided, a definitive root cause for the torn threads of the screw cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head of the screw.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, 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 EXP VERSE FEN SCR 4.35X40
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9321119
• Report Number: 1526439-2019-52428
• Device Sequence Number: 10862417
• Product Code: PML
• UDI-Device Identifier: 10705034403434
• UDI-Public: (01)10705034403434
• Combination Product (Y/N): N
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 199723440
• Device Catalogue Number: 199723440S
• Device Lot Number: AVKBOG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 11/25/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 11/18/2019; 11/25/2019
• Patient Sequence Number: 1