MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM LONG AO PILOT DRILL; NAIL, FIXATION, BONE

Catalog Number 71631121

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

Patient Problem Foreign Body In Patient (2687)

Event Date 09/25/2016

Event Type  Injury  

Manufacturer Narrative

Two devices of the same type, of different lot numbers broke during the same procedure, both leading to same impact.Other device breakage was reported under mdr 1020279-2017-00723.

Event Description

It was reported that during a femoral nailing procedure, the long 4.0 mm pilot drill used to drill proximal holes for femoral antegrade nail screws broke off and remained lodged in patient's left femur.It was not possible to retrieve broken drill tip ends (1 inch in length).

Manufacturer Narrative

The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).

Manufacturer Narrative

The associated complaint device was returned for evaluation.Please see attached the results of our investigation.(b)(4).

• Brand Name: 4.0MM LONG AO PILOT DRILL
• 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: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 6851472
• MDR Text Key: 85298899
• Report Number: 1020279-2017-00724
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010497468
• UDI-Public: 03596010497468
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71631121
• Device Lot Number: 16FM16509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2016
• 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): Other