MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM VERSE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	199721740
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned for evaluation.Investigation will be conducted.Follow up will be filed with findings.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
The screw was inserted without no problem however when the rod was placed and correction maneuver carried out the surgeon could not get a locking cap into the head of the screw.We tried 2 locking caps and this still did not sit properly and unfortunately resulted in the rest of the locking caps being removed and rod removed for him to have to replace the screw.I have looked at the screw and it looks it was damaged.Please can this be investigated and a replacement sent out.
Additional Manufacturer Narrative
Visual examination of the returned device revealed threads were torn and the drive feature was stripped.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 cannot be positively determined.However, a likely root cause maybe inadvertently cross threading occurred coupled with unexpectedly high amounts of force being placed 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: EXPEDIUM VERSE
• 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: 6910275
• Report Number: 1526439-2017-10789
• Device Sequence Number: 10920904
• Product Code: NKB
• UDI-Device Identifier: 10705034442112
• UDI-Public: (01)10705034442112
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142185
• 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): 08/03/2017

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: 199721740
• Device Catalogue Number: 199721740
• Device Lot Number: 101339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 11/14/2017
• Patient Sequence Number: 1