MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø10X360 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18451036S

Device Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

At (b)(6) 2017, the operation with t2 reconstruction nail was done for fracture of shaft of femur.After operation, the nonunion was confirmed.At (b)(6) 2018, nail fracture was confirmed.Medical history: collagen disease (take an steroids by mouth), diabetes, osteoporosis.Doctor's opinion: diabetes mellitus and progress of osteoporosis due to oral steroids for collagen diseases, and loading on the nail due to nonunion.

Manufacturer Narrative

The reported event that reconstruction nail r1.5, ti, right t2 recon ø10x360 mm x 125° was alleged of 'implant breakage - nail' 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 such as the patient's details, his activity level post op, x-rays, as well as the affected device must be available in order to determine the root cause of the complaint event.In general, a nail will be subject of a (fatigue) fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation.The affected implant is designed to withstand the normal loads during the implantation period, i.E.The implant must neither be exposed to peak loads nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.This state must be achieved within a medically recognized period (confirmed by scientific analysis about 6 months) in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.Material damage, even if unintentional, will reduce the implant¿s durability in such a way that a breakage is to be expected.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device not returned.

Event Description

At (b)(6) 2017, the operation with t2 recontraction nail was done for fracture of shaft of femur.After operation, the nonunion was confirmed.At (b)(6) 2018, nail fracture was confirmed.Medical history: collagen disease(take an steroids by mouth), diabetes, osteoporosis.Doctor's opinion: diabetes mellitus and progress of osteoporosis due to oral steroids for collagen diseases, and loading on the nail due to nonunion.

• Brand Name: RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø10X360 MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7245354
• MDR Text Key: 99148485
• Report Number: 0009610622-2018-00041
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K102992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 18451036S
• Device Lot Number: K0C9529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR