MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179712640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 a 6.0 x 40 pedicle screw shaft broke during a revision procedure on (b)(6) 2019.The shaft broke away from the head of the screw as the surgeon was attempting to remove it.Thankfully the screw was removed using the operace reamer.The removal was achieved easily.There was approximately forty-five (45) minutes surgical delay to remove the damaged pedicle screw.Procedure was completed successfully.The reason for the revision was further degeneration of the spine there were no issue with the implants.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).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.Product was not returned.Reviewing attached picture the breakage can be confirmed.The breakage occurred between the head and the shaft.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.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).H6: patient code: surgery prolonged.

• Brand Name: SI POLYAXL SCREW 6 X 40MM
• 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: 9376677
• Report Number: 1526439-2019-52502
• Device Sequence Number: 18925917
• Product Code: NKB
• UDI-Device Identifier: 10705034067728
• UDI-Public: (01)10705034067728
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/01/2019

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: 179712640
• Device Catalogue Number: 179712640
• Device Lot Number: 191542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 12/05/2019; 12/27/2019; 01/28/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/03/2019; 12/05/2019; 01/03/2020; 01/29/2020
• Patient Sequence Number: 1