MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COM SCREW KIT 115/110; NAIL, FIXATION, BONE

Model Number 71677115

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 11/23/2016

Event Type  Injury  

Event Description

During a removal of intertan nail due to pain (will be reported separately), the lag screwdriver was engaged to lag screw but lag screw would not turn despite appropriate amount of force.Lag screwdriver retaining rod x2 damaged in trying to remove the lag screw.And the end of the lag screw was also damaged, with it having to be left inside the patient.Surgery time was extended for two hours.

Manufacturer Narrative

The associated device for this complaint was not returned for evaluation.

• Brand Name: LAG/COM SCREW KIT 115/110
• Type of Device: NAIL, FIXATION, BONE
• 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: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6168953
• MDR Text Key: 62187592
• Report Number: 1020279-2016-00944
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

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: 02/28/2019
• Device Model Number: 71677115
• Device Catalogue Number: 71677115
• Device Lot Number: 09CM00138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2009
• 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
• Patient Outcome(s): Other
• Patient Age: 47 YR