MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREWDRIVER RELEASE HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71674084
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, the tip of a screwdriver release handle was twisted.Item is broken, and no longer functioning as expected.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that the tip of a screwdriver release handle was twisted and that no piece is broken off.The reassessment determined that the issue does not meet the threshold for reporting and therefore, it is a non-reportable event.If further details are provided, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: SCREWDRIVER RELEASE HANDLE
• 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: 18514877
• Report Number: 1020279-2024-00120
• Device Sequence Number: 15250903
• Product Code: HSB
• UDI-Device Identifier: 03596010560810
• UDI-Public: 03596010560810
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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
• Device Catalogue Number: 71674084
• Device Lot Number: 10KM13347
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown