MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT HEX RC SCR BL 6.4X100; NAIL, FIXATION, BONE

Catalog Number 71642300

Device Problems Failure To Adhere Or Bond (1031); Positioning Problem (3009)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 01/16/2017

Event Type  Injury  

Manufacturer Narrative

It has been reported that only the screws will be sent for investigation.

Event Description

It was reported that a significant extension of surgical procedure occured due to insertation of screws outside of the screw hole of femoral nail using a radiolucent drop device.Surgeon had removed the femoral nail implant, implanted it again using new set of screws and the same radolucent drop device.

Manufacturer Narrative

(b)(4).

• Brand Name: INT HEX RC SCR BL 6.4X100
• 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: 6275815
• MDR Text Key: 65692958
• Report Number: 1020279-2017-00055
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981529
• 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,Followup,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Catalogue Number: 71642300
• Device Lot Number: 13HM19800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2013
• 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: INT HEXRCSCR BL6.4X100,PART#71642300,LOT#13HM19800
• Patient Outcome(s): Hospitalization; Required Intervention