MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 TI CORT FIX 6X40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	186731640
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
Surgeon was finally tightening the set screws in a l2-s1 percutaneous lumbar fusion when the s1 set screw on the left side of the patient would not torque out.Upon inspection, the set screw was not flush with the top of the tulip head.All set screws and the rod were removed.The left s1 screw was then removed and a new screw was inserted.Rod and set screws were then reinserted and all set screws were finally tightened to the appropriate torque.Patient consequence? :yes.Patient consequence description:increased anesthesia time.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the returned device found that the initial thread on the tulip head of the polyaxial screw had become torn.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 polyaxial¿s tulip head threads becoming torn cannot be positively determined.However, the observed damage suggests that inadvertently cross threading occurred between the setscrew and the tulip head threads upon 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: 5.5 TI CORT FIX 6X40MM
• 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: 7139683
• Report Number: 1526439-2017-50124
• Device Sequence Number: 912813
• Product Code: NKB
• UDI-Device Identifier: 10705034351827
• UDI-Public: 10705034351827
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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: Health Professional
• Device Catalogue Number: 186731640
• Device Lot Number: AVHBWC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR