MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE TS AXSOS FOR LEFT FEMUR 16 HOLE / L343MM; PLATE, FIXATION, BONE

Catalog Number 437516

Device Problem Bent (1059)

Patient Problem Non-union Bone Fracture (2369)

Event Date 02/27/2016

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that a left distal femur plate was revised.Sales rep received a call from surgeon stating that patient presented with a bent plate (30-40 degrees) - patient stated no trauma involved in matter.Surgeon removed the plate and 15 screws.Surgeon realized mal union and performed an osteotomy and used external fixation to restore better anatomy.

Manufacturer Narrative

Device will not be returned since it was lost.If additional information becomes available it will be provided on a supplemental report.The reported incident that distal lateral femur plate ts axsos for left femur 16 hole / l343mm was alleged of issue s-16 (device deformed) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, note that it was reported that the surgeon noticed mal union of the bone, which is clearly described in the instructions for use as an adverse effect which can cause the device failure due to metal fatigue.Note, as stated in the ifu (v15013): ¿adverse effects in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: delayed union or non-union of the fracture site.These devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was lost.

Event Description

It was reported that a left distal femur plate was revised.Sales rep received a call from surgeon stating that patient presented with a bent plate (30-40 degrees) - patient stated no trauma involved in matter.Surgeon removed the plate and 15 screws.Surgeon realized mal union and performed an osteotomy and used external fixation to restore better anatomy.

• Brand Name: DISTAL LATERAL FEMUR PLATE TS AXSOS FOR LEFT FEMUR 16 HOLE / L343MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5520737
• MDR Text Key: 41006335
• Report Number: 0008031020-2016-00145
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061012
• 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: 02/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 437516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• 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