MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS CANNULATED X-TAB 7X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186770045
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
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 during spinal fixation surgery on (b)(6) 2019, the screwdriver lost connection to the implant during insertion of the implant.Reinsertion of the screwdriver was not possible and after some manipulation the surgeon managed to remove the implant again.Once the implant was removed the surgeon noticed that the inner-bushing in the screwhead had come loose and was free-floating in the screwhead (this bushing locks the polyaxiality when the setscrew is tightened).The implant was replaced with another screw and the surgery was completed successfully.No harm was caused to the patient.The surgery time was lengthened for approximately ten (10) minutes, but surgery was completed successfully.This is report 1 of 1 for complaint (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.Visual inspection of the complaint device showed the implant not broken instead the tulip head, bushing, and sleeve have separated from the screw shank, allowing it to spin freely with no resistance 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.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.

• Brand Name: MIS CANNULATED X-TAB 7X45MM TI
• 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: 9377928
• Report Number: 1526439-2019-52508
• Device Sequence Number: 3077620
• Product Code: NKB
• UDI-Device Identifier: 10705034129679
• UDI-Public: (01)10705034129679
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K160904
• 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): 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186770045
• Device Catalogue Number: 186770045
• Device Lot Number: 240947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/23/2019
• Patient Sequence Number: 1