MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA 9X345 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1822-0934S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Limb Fracture (4518)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The sales rep reported that : "pose the nail on an alcoholic patient, very agitated (in dt), (b)(6).Return to his room, very disturbed, moves around a lot, falls from his height.Nail fracture above the distal holes.Reoperation on (b)(6) 2020 for removal of the broken material and installation of an external fixator because of open fracture.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail is completely broken in the webs of the distal screw hole.The point of origin is clearly visible on the microscopic images.The fracture pattern resembles a fatigue fracture, evident by progression lines pointing to the origin of the fracture.The fracture analysis represents shiny surface, which is generally a sign of fatigue fracture, when the device gradually breaks and rub against each other due to high repeated cyclic loading.There is no plastic deformation.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.Based on investigation, the root cause was attributed to a patient factor related issue i.E.Fall from height and alcoholic.The ifu also states ¿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, osteomalicia, 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.¿ if any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The sales rep reported that : "pose the nail on an alcoholic patient, very agitated (in dt), 110kg.Return to his room, very disturbed, moves around a lot, falls from his height.Nail fracture above the distal holes.Reoperation on (b)(6) 2020 for removal of the broken material and installation of an external fixator because of open fracture.".

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA 9X345 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; GM D-24232
• MDR Report Key: 11189770
• Report Number: 0009610622-2021-00239
• Device Sequence Number: 3477244
• Product Code: HSB
• UDI-Device Identifier: 04546540197788
• UDI-Public: 04546540197788
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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: 09/30/2025
• Device Model Number: 1822-0934S
• Device Catalogue Number: 18220934S
• Device Lot Number: K087298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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 Weight: 110