MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH K-WIRE TENXOR Ø 2 X 450MM; PIN, FIXATION, SMOOTH

Catalog Number 51012450

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 09/10/2014

Event Type  Injury  

Event Description

The proximal tibia wires lost tension from the connecting wire bolts.The patient was weight bearing on the frame, which caused the wires to loose tension.The wires were removed under anesthesia in the operating room and replaced with 2mm olive wires and new wire bolts, which tensions the tibia in a static position.

Manufacturer Narrative

The device will not be returned.Additional information was requested and if received will be provided on a supplemental report.

Manufacturer Narrative

Evaluation summary: the reported event that hoffmann lrf k-wire tenxor lost tension after surgery could not be confirmed, since the device was not returned for evaluation.Based on investigation, the root cause of the determined poor fixation was attributed to a patient related issue.The hoffmann lrf k-wire tenxor lost of tension was caused by overloading.It was reported that ¿the patient was weight bearing on the frame, which caused the wires to loose tension¿, then the activity of the patient less than 2 weeks after implantation was not appropriate.Moreover, the patient is obese ((b)(6)).Please note that literature reads: "attention operating surgeon these devices are intended only to assist healing and are not intended to replace normal bone structures.[¿] no such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal healthy bone." [original statement] "the following factors are of extreme importance to the eventual success of the procedure.The patient¿s weight.An overweight or obese patient can produce higher loads on the device which can lead to failure of the device.The effect of these loads will be accentuated when a small sized device must be used because of bone size.Patient¿s activity.If the patient¿s activity comprises significant impact loads (walking, running, lifting or turning) the resulting forces could lead to failure of the fixation, the system or both.The system will not restore function to the level expected with normal healthy bone, and the patient should not have unrealistic functional expectations.(see precautions section for more information) "precautions the surgeon should evaluate the possibility of subsequent clinical failure, and discuss with the patient the need for reduced activity levels, and/or possible revision surgery in order to aid fracture healing.The surgeon should discuss all physical and psychological limitations inherent in the use of external fracture fixation appliances with the patient.Particular attention should be given to premature weight bearing, activity levels and the necessity for periodic medical follow-up.The surgeon must warn patients of surgical risks, and make them aware of possible adverse effects.The patient should be warned that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity or trauma." [original statement.] a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Indications for any material, manufacturing or design related problems were not determined in the investigation.If any further information is provided, the investigation report will be updated.

Event Description

The proximal tibia wires lost tension from the connecting wire bolts.The patient was weight bearing on the frame, which caused the wires to loose tension.The wires were removed under anesthesia in the operating room and replaced with 2mm olive wires and new wire bolts, which tensions the tibia in a static position.

• Brand Name: K-WIRE TENXOR Ø 2 X 450MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4296233
• MDR Text Key: 22165077
• Report Number: 0008031020-2014-00573
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51012450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 12/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 125