MAUDE Adverse Event Report: STRYKER GMBH DIST. LAT. FEMUR PLATE 20 HOLE / 414MM RIGHT; PLATE, FIXATION, BONE

Catalog Number 627650

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Non-union Bone Fracture (2369)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Customer reported that axsos3 distal lateral femoral plate was removed from patient and replaced with a non-stryker nail because of delayed union.

Event Description

Customer reported that axsos3 distal lateral femoral plate was removed from patient and replaced with a non-stryker nail because of delayed union.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.The device inspection revealed the following: scratches were found on the surface of the plate.No major deformation or damages were found in the returned devices.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by delayed union.As per ifu ¿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.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.As conveyed in ifu, delayed union is the most frequent adverse effects involving the use of internal fracture which may be clinically related rather than device related.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: DIST. LAT. FEMUR PLATE 20 HOLE / 414MM RIGHT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8449422
• MDR Text Key: 139755169
• Report Number: 0008031020-2019-00308
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 627650
• Device Lot Number: V26598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR