MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE SCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 7X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
On (b)(6) 2017, the surgery for spinal canal stenosis was performed using the expedium system.During the surgery, although the surgeon tried to put a rod (part#: unk) into the screw, a set screw (part#: unk) could not be set because the screw-head of the reported product (part#:186731750 / lot#:140823) got broken.The surgeon dealt with this event by adjusting the bending of the rod and replacing the reported product with a new one.No broken parts were confirmed to be left in the body and the surgery was successfully done with a 30-minute delay.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Visual examination of the returned device found the top three threads were completely torn off.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.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the inner threads of the polyaxial¿s screw tulip head becoming torn cannot be positively determined.However, visual examination suggests inadvertently cross threading during insertion.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, 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, 7X50MM
• 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: 6764281
• Report Number: 1526439-2017-10626
• Device Sequence Number: 16516775
• Product Code: NKB
• UDI-Device Identifier: 10705034352022
• UDI-Public: (01)10705034352022
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2017

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: 186731750
• Device Catalogue Number: 186731750
• Device Lot Number: 140823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 08/21/2017; 09/21/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 08/25/2017; 09/25/2017
• Patient Sequence Number: 1
• Patient Age: 61 YR