MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SFX,5.5,TI, LAT, SIZE F2; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	189401102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
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
Account name: (b)(6) hospital.On (b)(6) 2017, surgery for pelvic fracture was performed using the expedium sai and sfx system.The fixed area was s2 a1.The following events were confirmed during the surgery.The surgeon attempted a final tightening after completion of sai screw insertion and rod placement.Then, he tried to insert the transversal connector f2/18mm (part#:189401102, lot#: unknown) using a self-retaining inserter, however, this transversal connector got stripped and broken.Finally, he replaced this transversal connector with another size of transversal connector f1/16mm (part#: 189401101, lot#: unknown), and insertion was successful.No broken parts were found left in the body, and the surgery was completed without any delay.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the transversal connector revealed signs of operative usage with drive feature of the set screws worn.It was also noted that one of the set screws and the connector has damaged threads, consistent with the cross threading while insertion.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 determined for the stripped threads on the set screw and the connector.However, a potential root cause may be due to cross-threading the set-screw 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: SFX,5.5,TI, LAT, SIZE F2
• 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: 7080492
• Report Number: 1526439-2017-50038
• Device Sequence Number: 13768092
• Product Code: NKB
• UDI-Device Identifier: 10705034167688
• UDI-Public: 10705034167688
• Combination Product (Y/N): N
• 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): 11/09/2017

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: 189401102
• Device Lot Number: OM9464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR