MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA 8X300 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1822-0830S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Neuropathy (1983); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that the patient's left tibia was revised due to the tibial nail breaking at the most proximal distal hole of the device while patient was walking.Reported patient factors: diabetes, diabetic neuropathy.
Additional Manufacturer Narrative
The reported event that a tibial nail, standard t2 tibia ø8x300 mm had broken after approx.4 months of implantation was confirmed on provided medical records.The review of manufacturing documents revealed no deviation in the manufacturing process.Required material properties had been confirmed prior to manufacturing.As no item was returned no physical examination could be carried out.Potential implant breakage had been considered in the risk management file with appropriate values not having been exceeded by this case.The labelling already informs about that a temporary implant requires sufficient bone consolidation in order to relieve the nail during the implantation period.The labelling also points out potential reasons for insufficient bone healing ¿ e.G.But not limited to osteoporosis and / or diabetes and points out that an intra-operatively damaged implant is at risk for breakage.In the case presented a tibia nail had broken in fatigue manner after an implantation period of approx.4 months.Although the implant was not available for investigation a medical review of provided medical records revealed the nail broke almost horizontally at the metaphysis of the bone.The cavity of the bone is getting wider so that movement occurs; resulting in pseudarthrosis.It was identified that the clinical situation in an obese patient with dm and diabetic neuropathy was at high risk of failure due to the patient¿s condition and the location and orientation of the fracture.There was no obvious technical mistake apparent on the x-rays.No indications of material, manufacturing or design related problems were found during the investigation.Primarily the nail had broken due to patient¿s conditions.In case the item itself and / or further essential information becomes available we reserve the right to reopen the investigation with new root cause assessment.
Event or Problem Description
It was reported that the patient's left tibia was revised due to the tibial nail breaking at the most proximal distal hole of the device while patient was walking.Reported patient factors: diabetes, diabetic neuropathy.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA 8X300 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9862851
• Report Number: 0009610622-2020-00116
• Device Sequence Number: 3307900
• Product Code: HSB
• UDI-Device Identifier: 04546540197627
• UDI-Public: 04546540197627
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: 1822-0830S
• Device Catalogue Number: 18220830S
• Device Lot Number: K072BD0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 83