MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH LOCKING RECONSTRUCTION PLATE AXSOS 10 HOLE / L120MM 4.0MM LOCKING SET; PLATE, FIXATION, BONE

Catalog Number 427040S

Device Problems Bent (1059); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 10/20/2014

Event Type  Injury  

Event Description

The patient is noncompliant and bending the plate.The broken plate was seen on x-rays, and confirmed by the doctor to be bent.

Manufacturer Narrative

Evaluation summary: the reported event of the patient is being noncompliant and bending the plate for locking reconstruction plate axsos 10 hole / l120mm 4.0mm locking set could be confirmed.Since the event description mention that the patient is being noncompliant and bending the plate the root cause is patient related e.G.User related.Notes: ¿the physicians¿ education, training and professional judgement must be relied upon to choose the most appropriate device and treatment.Conditions presenting an increased risk of failure include: any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.Post-operative patient activity: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason postoperative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.The risk of postoperative complication (e.G.Failure of an implant) is higher if patients are obese and/or cannot follow the recommendations of the physician because of any mental or neuromuscular disorder.For this reason those patients must have additional postoperative follow up.(v15013 k non active implant ifu) a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Device remains implanted.

• Brand Name: LOCKING RECONSTRUCTION PLATE AXSOS 10 HOLE / L120MM 4.0MM LOCKING SET
• Type of Device: PLATE, FIXATION, BONE
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4258499
• MDR Text Key: 18927869
• Report Number: 0008031020-2014-00549
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2014

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: Lay User/Patient
• Device Catalogue Number: 427040S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 11/18/2014
• 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: 48