MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SD HANDLE - LRG; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Model Number 71179213

Device Problems Break (1069); Connection Problem (2900)

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

Event Date 04/16/2021

Event Type  malfunction  

Event Description

It was reported that the screwdriver handle-large broke.In addition, when it was tried to tighten the proximal screw, it wouldn't tighten any further, it would just keep spinning (almost like it had a torque limiter on it).This happened outside the patient, no injury was reported.It is unknown if there was a significant delay.Procedure was finished using a smith and nephew back up device.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode but could confirm that the device is discolored.The device shows signs of extensive use.The device shows signs of extensive use.A functional evaluation of the returned product confirmed the stated failure mode.The device was paired with the mating part but could not function, rendering the device inoperable.A review of complaint history did not reveal additional complaints for the listed device.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: SD HANDLE - LRG
• Type of Device: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11794310
• MDR Text Key: 249672796
• Report Number: 1020279-2021-03855
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 00885556533185
• UDI-Public: 00885556533185
• Combination Product (y/n): N
• PMA/PMN Number: K152686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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: 71179213
• Device Catalogue Number: 71179213
• Device Lot Number: 15ETF0005
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/02/2021
• Patient Sequence Number: 1