MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE SCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 8X45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731845
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Lot unknown.Awaiting sample: a follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not yet returned for evaluation.
Event or Problem Description
Implant broke during insertion.Complaint form sent to rep per complaint form: when placing the revision screw, the screwdriver made a popping noise which was the tip of the driver breaking.The tip was stuck in the screw and we had to attach a rod to remove.We broke off the head of the screw attempting to remove and then used a reverse threaded removal tip in order to remove the screw shaft.
Additional Manufacturer Narrative
Udi: (b)(4).Visual examination of the cortical fix bottom loading shank 8x45mm polyaxial screw found that the tulip head had become detached from the polyaxial¿s screw shank.Observations suggest that unanticipated high amounts of force were placed on the tulip head resulting in the tulip head becoming detached from the polyaxial¿s screw shank.Dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.A definitive root cause for the polyaxial screw¿s tulip head becoming detached from the polyaxial screw¿s shank cannot be positively determined.However, observations suggest that unanticipated high amounts of force were placed on the tulip head resulting in the tulip head becoming detached from the polyaxial¿s screw shank.As there has been no issues identified in the manufacturing or release of this device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, 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: SCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 8X45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6824164
• Report Number: 1526439-2017-10714
• Device Sequence Number: 11090879
• Product Code: NKB
• UDI-Device Identifier: 10705034352190
• UDI-Public: (01)10705034352190
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/02/2017

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: Physician
• Device Model Number: 186731845
• Device Catalogue Number: 186731845
• Device Lot Number: ARLC39
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 09/25/2017
• Patient Sequence Number: 1
• Patient Age: 68 YR