MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 9X80; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727980
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
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
Revision surgery for same patient as (b)(4).One iliac screw cfx 9x80 broke post op, aprox 2-3 months after surgery.With help of a screwdriver, the surgeon could remove the head and the proximal portion of the screw shank.As to the distal portion of the screw shank, surgeon tried to remove it with a reamer but didn¿t have one large enough to remove a 9 mm diameter screw, so they left it in.They then decided to remove the second 9 mm iliac screw.They couldn¿t insert the screwdriver in the screw head because the tip of the broken screwdriver from the previous surgery was still left in the head (previous complaint report).They decided to insert a small rod in the screw head and to lock it with a set screw to monoaxialize the iliac screw.However, upon unscrewing, the screw head broke.They removed it from the shank and tried unscrewing the screw shank with various instruments but failed to do so.The surgeon finally decided to leave the second broken screw in as well.To be able to finalize the construct the surgeon has used sai screws.Thanks to the alternative trajectory sai screws allow, they could implant them without conflicting with the iliac shanks from the previous surgery that couldn¿t be removed.Afterwards, the surgeon has put back new rods and innies.Upon final tightening one set screw, the torque tip flattened.Patient consequence? :yes.Patient consequence description:radicular pain and difficulties to walk.Action taken for procedure:wanted to remove broken screws but didn¿t have a 9 mm reamer.Left broken screws in and implanted sai screws to finalize the construct.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
(b)(4).Visual examination of the tulip head of the screw was returned with its saddle intact and the shank missing which revealed significant worn from the operative usage.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.With the information provided, a definitive root cause for the intraoperative breaking of the screw cannot be determined.However, it was noted from the complaint that a significant amount of force was applied to extract the screw which could be a potential reason for the breaking.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 9X80
• 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: 7707626
• Report Number: 1526439-2018-50702
• Device Sequence Number: 1365292
• Product Code: PML
• UDI-Device Identifier: 10705034282961
• UDI-Public: (01)10705034282961
• 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
• Report Date (Section B): 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186727980
• Device Catalogue Number: 186727980
• Device Lot Number: AVBBL8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention