MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.7MM HEXDRIVER SHAFT W/ QC; SCREWDRIVER

Model Number 71177158

Device Problems Material Deformation (2976); Unclear Information (4052)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2020

Event Type  Injury  

Event Description

It was reported that the patient was injured but the surgeon says that the patient seems stable.No further information is available at the moment.

Manufacturer Narrative

The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device has signs of wear and tear from use.The device was manufactured in 2011.According to clinical/medical investigation, per complaint details, the ¿patient was injured but the surgeon says that the patient seems stable¿.Responses to the requested clinical documentation/information was not provided for inclusion in a medical investigation; therefore, the root cause of the reported injury could not be assessed.Per the product evaluation, the instrument which was manufactured in 2008 shows signs of wear and tear.The patient impact beyond the reported ¿injury¿ could not be determined, as reportedly the surgeon noted the patient seemed stable and no further information was provided.Should additional information/ documentation become available, the clinical/medical task may be re-opened for further evaluation.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.

• Brand Name: 4.7MM HEXDRIVER SHAFT W/ QC
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10715307
• MDR Text Key: 212444204
• Report Number: 1020279-2020-05636
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 03596010601582
• UDI-Public: 03596010601582
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 71177158
• Device Catalogue Number: 71177158
• Device Lot Number: 08FM06075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other