MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 125 RAD DRILL GDE DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71674002

Device Problem Connection Problem (2900)

Patient Problem Injury (2348)

Event Date 10/27/2017

Event Type  Injury  

Event Description

It was reported that surgical time was extended due to connection issues between drill sleve and guide drop.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.[(b)(4)].

• Brand Name: 125 RAD DRILL GDE DROP
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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; SZ 05001
• MDR Report Key: 7028410
• MDR Text Key: 91922976
• Report Number: 1020279-2017-01025
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010570970
• UDI-Public: 03596010570970
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122170
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71674002
• Device Lot Number: 08HGT0007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 125 RAD DRILL GDE DROP/71674002/08HGT0007
• Patient Outcome(s): Required Intervention