MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 7X65; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727765
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that - the head of the screw was disassembled when the alignment guide was introduced with a hammer for inserting the lock cap in a viper cortical fix fenestrated screw.The square thread of 2 verse correction keys were broken when they were inserted in the head of the screw.Was surgery delayed due to the reported event? --> no, action taken when event occurred? --> to change the screw and the correction keys, was procedure successfully completed? --> yes, were fragments generated? --> yes, if yes, were they removed easily without additional intervention? --> yes, patient status/ outcome / consequences --> no, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> no, is the patient part of a clinical study --> no.
Additional Manufacturer Narrative
Product complaint # (b)(4).The viper cortical fix fenestrated screw was returned disassembled.All four (4) subcomponents were returned with only the flex ball and shank still assembled together.The subcomponents can be reassembled, but the head and cap do not fit together in a secure manner, allowing the flex ball and shank to pop out of the head.No other issues were identified with the returned portions.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 complaint is confirmed.The cap should be swaged into the head while leaving the flex ball and shank free to swivel.Instead, the device was received with the cap and the head unattached, allowing all but the flex ball and shank to disassemble.Although, the head and cap show signs of having been staked together, so it is unclear when the two came apart.There is no indication that a design or manufacturing issue contributed to the complaint.The definitive root cause could not be identified that contributed to the complaint condition.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: MIS TI CFX FEN POLY 7X65
• 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: 8416828
• Report Number: 1526439-2019-51446
• Device Sequence Number: 19321447
• Product Code: PML
• UDI-Device Identifier: 10705034282718
• UDI-Public: (01)10705034282718
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

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 Model Number: 186727765
• Device Catalogue Number: 186727765
• Device Lot Number: APNDJ4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1