MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL GUIDE HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71674001

Device Problem Difficult to Remove (1528)

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

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported the bolt of intertan nail couldn't unscrew with wench to dismantle jink from screw.Surgery time was extended over 30 minutes.

Manufacturer Narrative

(b)(4).

• Brand Name: DRILL GUIDE HANDLE
• 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: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 9013995009
• MDR Report Key: 6422288
• MDR Text Key: 70521573
• Report Number: 1020279-2017-00202
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K122170
• 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
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71674001
• Device Lot Number: 13ACL0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR