MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 8X55; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727855
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Screw head declamped (no breakage) intraoperatively from screw shaft during screw insertion (expedium cfx 186727855).Screw insertion was performed using the mis alignment device (2797-26-400) and an srt adapter and t handle.Screw head declamped half way in the pedicle.Screw shaft was then removed and a new screw was implanted using the regular screw driver.Patient consequence? unknown.Action taken for procedure:screw was removed and a new screw had to be implanted.Could have weakened the pedicle.New screw was augmented using confidence.Whether the screw will loosen must be monitored.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the returned device revealed that the screw head was disassembled from the shank, with broken saddle intact in the screw head.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 screw falling apart intraoperatively 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 screw disassembling 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: MIS TI CFX FEN POLY 8X55
• 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: 7474107
• Report Number: 1526439-2018-50434
• Device Sequence Number: 113509
• Product Code: PML
• UDI-Device Identifier: 10705034282800
• UDI-Public: (01)10705034282800
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018

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: 186727855
• Device Catalogue Number: 186727855
• Device Lot Number: ATBDLP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1