MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI POLY SCREW 11MMX80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179712280
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: kwp; kwq; mnh; mni.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the surgeons were revising a previous surgery that had developed pjk and showed signs of iliac screw failure.The patient's initial fusion (performed on (b)(6) 2019) was from t11-ilium, with expedium 5.5 and cortical fix implants placed from t11-l5, and nuvasive reline iliac bolts placed for the s2 sai screws (8.5 x 80mm screws).On (b)(6) 2020, the surgeon removed the nuvasive iliac bolts (from the patient's right side) and intended to implant dss viper sai iliac screws (1797-04-xxx).He used a viper 9.0 tap (2797-04-900) and the surgeon proceeded to pass a 10mm sai tap (2797-04-100) down through the prepared pathway, and he requested a 11x80mm iliac screw and proceeded to implant the 1797-12-280 screw.As the screw advanced through the prior pathway, he felt the screw was not advancing through the bone.At this time, he attempted to remove the iliac bolt from the bone but was unable to advance the screw in either direction (clockwise or counterclockwise).In this process, the polyaxial screw head broke from the iliac bolt and was removed from the patient.Attempted to remove the broken screw from the pelvis with the reverse conical extraction drivers from the universal removal set (srb) but could not fit the largest extraction driver over the 11mm screw.The surgeons were satisfied that the implant was not causing additional harm and elected not to continue to attempt to remove the broken screw.The shaft of the screw remains implanted in the patient.They continued with the procedure and placed new sai screws (medtronic) adjacent to the broken screw on the patient's right side.Fragments were generated and easily removed.There was a surgical delay of 60 minutes.Patient status is unknown.The procedure was successfully completed.This complaint involves four (4) devices.This is report 1 of 3 for (b)(4).Related product complaint: (b)(4).
Additional Manufacturer Narrative
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.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.
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Code (b)(4) used to capture modified surgical procedure.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.

• Brand Name: EXP TI POLY SCREW 11MMX80MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10111235
• Report Number: 1526439-2020-01098
• Device Sequence Number: 16800845
• Product Code: NKB
• UDI-Device Identifier: 10705034067070
• UDI-Public: 10705034067070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2020

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: 179712280
• Device Catalogue Number: 179712280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 06/03/2020; 06/12/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/11/2020; 06/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM EXTENDED CANULATED TAP.; 9MM EXTENDED CANULATED TAP.; UNKNOWN EXTRACTION INSTRUMENTS.
• Outcome Attributed to Adverse Event: Required Intervention