MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 11.5MM X 40CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71649740

Device Problems Difficult to Remove (1528); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2017

Event Type  malfunction  

Event Description

It was reported that upon taking final xrays it was noticed on the lateral that the screws had split apart and almost looked like they are overlapping.The surgeon tried to take the screw out and reinsert but was not successful.

Manufacturer Narrative

(b)(4).

• Brand Name: META-TAN 11.5MM X 40CM LEFT
• 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 05001 ; SZ 05001
• MDR Report Key: 6601237
• MDR Text Key: 76498999
• Report Number: 1020279-2017-00378
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556340899
• UDI-Public: 00885556340899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71649740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: 05/01/2017
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• 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