MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER MONO SCREW 7X40MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186717740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The viper mono screw was not returned to the customer quality unit for evaluation.Thus, an investigation will be based on a no sample device evaluation.Should more information and/or the device sample become available at a later date, this complaint file will be reopened and the device will then receive a full evaluation.A device history record review identified no issues during the manufacturing and release of this instrument 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.Without the return of the mono screw we are unable to confirm the reported issue or identify the root cause.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Therefore, 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.
Event or Problem Description
On (b)(6) 2017, the surgery for traumatic injury was performed by using the viper 2 spine system.The fixed area was l1.On (b)(6) 2018, during the planned removal surgery, it was found that 2 x viper mono screw (186717740) had been broken at the base of its screw head.The two broken screws were extracted by removing the area around the two broken screws using a chisel.The removal surgery was successfully completed, and there was no adverse consequence to the patient.The surgeon comments that this event may have occurred because the screws were in unstable position caused by vertebral nonunion.

• Brand Name: VIPER MONO SCREW 7X40MM TI
• Common Device Name: 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: 7591600
• Report Number: 1526439-2018-50538
• Device Sequence Number: 11187189
• Product Code: NKB
• UDI-Device Identifier: 10705034123639
• UDI-Public: (01)10705034123639
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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: 186717740
• Device Catalogue Number: 186717740
• Device Lot Number: RL249818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention