MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 80/75; NAIL, FIXATION, BONE

Catalog Number 71677080

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/25/2017

Event Type  malfunction  

Event Description

It was reported that following implantation of femoral nail for intertrochanteric fracture the lag screw is backing out about 5 mm but compression screw a lot.Fracture was being reduced well intra-op.Patient is doing fine with daily routine, no active sports activities, no pain.Due to no pain the surgeon did not take any actions and patient will be monitored.

• Brand Name: LAG/COMP SCREW KIT 80/75
• 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 5001 ; SZ 5001
• MDR Report Key: 6499653
• MDR Text Key: 73227938
• Report Number: 1020279-2017-00272
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010563286
• UDI-Public: 03596010563286
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 09/19/2017

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: 71677080
• Device Lot Number: 15CT52970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: 03/25/2017
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INT HEX CAP SCR 5.0MM X 30MM, 71642230/16DM03706; INTERTAN 10S 10MM X 18CM 130D, 71675384/16HM20851