MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR 9X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18250936S

Device Problem Material Twisted/Bent (2981)

Patient Problems Failure of Implant (1924); Impaired Healing (2378)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "a young man, (b)(6) years old, fractured both thighs in a motorcycle accident on (b)(6) 2020 and bent the nail on the right side.The nail was changed on (b)(6) 2020 ( probably for delayed fracture healing).In the meantime, everything has healed well.From the hospital's point of view, the problem lies more in the delayed bone healing and a certain carelessness of the patient during the transition to full weight bearing.".

Event Description

As reported: "a young man, 17 years old, fractured both thighs in a motorcycle accident on (b)(6) 2020 and bent the nail on the right side.The nail was changed on (b)(6) 2020 (probably for delayed fracture healing).In the meantime, everything has healed well.From the hospital's point of view, the problem lies more in the delayed bone healing and a certain carelessness of the patient during the transition to full weight bearing.".

Manufacturer Narrative

The reported event could be confirmed, since visual inspection revealed a bent nail.The device inspection revealed the following: we received a femoral nail, a/r t2 femur ø9x360 mm for evaluation.Inspection revealed an obviously deformed nail shaft.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection: dimensional inspection [with exception of the damaged areas] revealed the nail dimensions to be as defined per drawing.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a patient related issue.The root cause was already given with the event description ¿from the hospital's point of view, the problem lies more in the delayed bone healing and a certain carelessness of the patient during the transition to full weight bearing.¿.

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR 9X360 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11041516
• MDR Text Key: 222678735
• Report Number: 0009610622-2020-01015
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K010801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 18250936S
• Device Lot Number: K032056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR