MAUDE Adverse Event Report: DEPUY SPINE INC TI X25 M7 SHORT SET SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179761000
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
It was reported screwdriver tip broke in the screw interface.When the surgeon tried to final tighten set screw on the rod, the set screw stripped and broke.We had to saw the head off the screw and then use a universal removal set and a reverse threaded driver to get the illiac screw out.
Additional Manufacturer Narrative
Product complaint # (b)(4).The set screw is stuck inside the expedium closed screw.The product and lot # could not be confirmed from the jammed set screw.The investigation is performed considering this set screw as the reported device from the complaint.It was also noted that the drive feature of the set screw is stripped in the direction of the tightening.The exact part and lot number combination could not be confirmed from the sample returned; therefore, the manufacturing or receiving inspection records could not be reviewed.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the jamming of the ti x25 m7 short set screw inside the closed screw cannot be determined.However, evidence from the stripped drive feature of the set screw this damage may have occurred due to cross-threading the set screw upon insertion.Tightening the set screw while it is cross threaded places an unexpectedly high amount of force on the threads both the set screw and the closed screw threads, resulting in jamming.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: TI X25 M7 SHORT SET SCREW
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7452233
• Report Number: 1526439-2018-50398
• Device Sequence Number: 11173284
• Product Code: NKB
• UDI-Device Identifier: 10705034077277
• UDI-Public: (01)10705034077277
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179761000
• Device Catalogue Number: 179761000
• Device Lot Number: TBHBZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention