MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE DRILL 35MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71362935

Device Problems Fracture (1260); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a thr, a flexible drill snapped.Surgery was resumed, after a non-significant delay, with a competitor device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

B5, d1, d2, d4, h6: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Event Description

It was reported that, during a thr, the shaft of the flexible drill was unraveling.Surgery was resumed, after a non-significant delay, with a competitor device.Patient was not injured as consequence of this problem.

• Brand Name: FLEXIBLE DRILL 35MM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 16372242
• MDR Text Key: 309568960
• Report Number: 1020279-2023-00317
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010464668
• UDI-Public: 03596010464668
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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 Operator: Health Professional
• Device Model Number: 71362935
• Device Catalogue Number: 71362935
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1