MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 18CM 125D; NAIL, FIXATION, BONE

Catalog Number 71675201

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 03/03/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on patient with a cognitive impairment.An alleged fall occured on (b)(6) 2017, however this is uncertain in terms of patient's dementia.It was reported that x-ray showed that the lag screw has turned itself up in acetabulum.

Manufacturer Narrative

(b)(4).

• Brand Name: INTERTAN 10MM X 18CM 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 ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6438399
• MDR Text Key: 70970429
• Report Number: 1020279-2017-00219
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010561046
• UDI-Public: 03596010561046
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71675201
• Device Lot Number: 16ET69578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 90 YR