MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 20CM 125D; NAIL, FIXATION, BONE

Catalog Number 71675205

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a surgery was extended over two hours due to a lag screw and nail binding up and due to difficulty removing the nail.The jammed nail was removed and another nail went in smoothly.

Manufacturer Narrative

(b)(4).

• Brand Name: INTERTAN 11.5MM X 20CM 125D
• 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 de santis ; 1450 brooks road; memphis, TN 38116 ; 0416283206
• MDR Report Key: 6373266
• MDR Text Key: 68842198
• Report Number: 1020279-2017-00150
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

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: 11/01/2021
• Device Catalogue Number: 71675205
• Device Lot Number: 11LM02602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: 02/21/2017
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2011
• 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
• Treatment: GUIDE PART# 71674002 LOT# UNKNOWN; HANDLE PART# 71674001 LOT# UNKNOWN; SCREW PART# 71677100 LOT# 16JT76380
• Patient Outcome(s): Hospitalization
• Patient Weight: 107