MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SELF HOLDING HEX SCREWDRIVER

Catalog Number 71110026

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/04/2015

Event Type  Injury  

Event Description

It was reported that the tip of the screw driver broke off and became stuck in screw head that was fully inserted into patient's hip.The tip was unable to be retrieved and remains implanted in patient.

Manufacturer Narrative

Hex screw driver was examined visually and using optical stereomicroscopy.From the analysis conducted it was concluded that the hex screw driver fractured by overload.An overload fracture can occur if the mechanical loads applied to the hex head exceed the strength of the material.It was unknown if the fracture was initiated in a prior surgery.A review of the manufacturing record did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history revealed no prior complaints for the listed lot.There is 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.

• Brand Name: SELF HOLDING HEX SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 4947906
• MDR Text Key: 16955030
• Report Number: 1020279-2015-00507
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2015

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 Expiration Date: 10/17/2012
• Device Catalogue Number: 71110026
• Device Lot Number: 02KM01919
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other