MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LONG HEXDRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, when tightening the screw, the internal catching device for the long hexdriver was broken inside.The tip of the inner catching device broke inside the screw head; therefore unable to remove it out since there is no more space in the screw head.Piece was retained inside the screw and left implanted in the patient as a result.Surgery was resumed, without any delay, with a back-up device.Patient was not harmed.No further complications reported.

• Brand Name: LONG HEXDRIVER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13996093
• Report Number: 1020279-2022-01486
• Device Sequence Number: 5317121
• Product Code: HSB
• UDI-Device Identifier: 03596010519269
• UDI-Public: 03596010519269
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 71631070
• Device Catalogue Number: 71631070
• Device Lot Number: 17DM10854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown